Wayne, NJ, United States
Maquet Cardiovascular, LLC recalls
26 recalls recorded since 2018, most recently on 2 June 2026. 20 are listed as ongoing. Status and classification are as published by the FDA.
Recalls26
Ongoing (FDA)20
Terminated or completed6
Class I (FDA)3
Ongoing Class II Medical devices
- Recall started
- 2 June 2026
- Reason
- Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
- Distribution
- US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2741-2026
- The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
Ongoing Class II Medical devices
- Recall started
- 15 August 2025
- Reason
- Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Sa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2586-2025, Z-2587-2025, Z-2588-2025
- Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
- Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
- Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Ongoing Class II Medical devices
- Recall started
- 6 August 2025
- Reason
- Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
- Distribution
- US Nationwide distribution in the states of FL, IL, MD & TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2636-2025
- Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use w
Ongoing Class II Medical devices
- Recall started
- 20 March 2025
- Reason
- There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Mexico, United Arab Emirates, Singapore, India, Australia, Canada, Brazil, Hong Kong, Japan, South Korea, New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1622-2025
- The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope, C-Ring, distal lens
Ongoing Class II Medical devices
- Recall started
- 10 March 2025
- Reason
- Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, FL, GA, IA, ID, IL, IN, KY, MD, MI, MN, MO, NC, NH, NJ, NY, OH, PA, PR, TX, UT, VA, WI, WV and the countries of China, Japan, Netherlands, New Zealand, Singapore, United Kingdom, United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1577-2025
- Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
Ongoing Class I Medical devices
- Recall started
- 9 December 2024
- Reason
- Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
- Distribution
- Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, Netherlands, New
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0711-2025, Z-0712-2025
- VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
- Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Ongoing Class II Medical devices
- Recall started
- 16 October 2024
- Reason
- Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
- Distribution
- Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembo
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0486-2025, Z-0485-2025, Z-0484-2025
- Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
- Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
- Acrobat-i Positioner. Model Number C-XP-5000Z
Ongoing Class I Medical devices
- Recall started
- 20 September 2024
- Reason
- There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
- Distribution
- Worldwide distribution. US Nationwide. Brazil, China, and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0092-2025
- VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
Ongoing Class II Medical devices
- Recall started
- 31 May 2024
- Reason
- There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.
- Distribution
- NationwideForeign: AT DE DK ES GB HK IT NL ZA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2337-2024, Z-2338-2024
- The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens
- The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens
Ongoing Class II Medical devices
- Recall started
- 17 May 2024
- Reason
- Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia Brazil, Canada, China, EEA, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, & United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2175-2024, Z-2176-2024
- The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2
- The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens
Ongoing Class I Medical devices
- Recall started
- 13 December 2023
- Reason
- Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
- Distribution
- Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0710-2024, Z-0709-2024
- Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
- Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Ongoing Class II Medical devices
- Recall started
- 1 December 2023
- Reason
- Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.
- Distribution
- US: OUS: China, Brazil, Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0723-2024, Z-0724-2024
- Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
- Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Ongoing Class II Medical devices
- Recall started
- 31 October 2023
- Reason
- The Positioner Arm may not tighten or lock during normal use.
- Distribution
- US Nationwide. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0589-2024
- Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Ongoing Class II Medical devices
- Recall started
- 19 September 2023
- Reason
- Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
- Distribution
- US (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0210-2024
- Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
Ongoing Class II Medical devices
- Recall started
- 13 September 2023
- Reason
- Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.
- Distribution
- Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0137-2024
- Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Ongoing Class II Medical devices
- Recall started
- 28 June 2023
- Reason
- The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Bangladesh, Brazil, Chile, Colombia, Iran, Jordan, Malaysia, Mexico, Netherlands, Singapore, Sudan, Taiwan, Thailand, and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2272-2023, Z-2271-2023, Z-2274-2023, Z-2273-2023
- ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
- ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.
- ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
- ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
Ongoing Class II Medical devices
- Recall started
- 6 March 2023
- Reason
- Some batches of product were not sterilized to their minimum sterilization specification.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Brazil, China.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1336-2023, Z-1337-2023, Z-1335-2023
- VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
- VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
- VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
Ongoing Class II Medical devices
- Recall started
- 30 January 2023
- Reason
- One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm.
- Distribution
- US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1245-2023
- Fusion Bioline Vascular Graft, Part number M00201503046B0
Ongoing Class II Medical devices
- Recall started
- 22 December 2022
- Reason
- Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.
- Distribution
- US Nationwide. Japan, Germany.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0996-2023, Z-0995-2023
- Vasoshield Syringe Packs, Model VH-5001
- Hemopro 2 with Vasoshield, Model VH-4001
Terminated Class II Medical devices
- Recall started
- 29 April 2022
- Terminated
- 18 April 2024
- Reason
- Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm
- Distribution
- US Nationwide distribution in the state of SC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1282-2022
- INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurat
Ongoing Class II Medical devices
- Recall started
- 9 February 2022
- Reason
- Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
- Distribution
- Worldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX, WI), Germany, Republic of Korea (South Korea), Russia, Thailand, United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0887-2022
- Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Terminated Class II Medical devices
- Recall started
- 14 January 2022
- Terminated
- 19 September 2023
- Reason
- Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm
- Distribution
- US Nationwide distribution in the state of MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0729-2022
- HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M
Terminated Class II Medical devices
- Recall started
- 1 December 2021
- Terminated
- 28 February 2024
- Reason
- There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.
- Distribution
- US Nationwide distribution in the states of IL and NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0403-2022
- Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Terminated Class II Medical devices
- Recall started
- 7 April 2020
- Terminated
- 5 November 2021
- Reason
- Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1876-2020, Z-1882-2020, Z-1871-2020, Z-1869-2020, Z-1861-2020, Z-1865-2020, Z-1875-2020, Z-1874-2020, Z-1866-2020, Z-1879-2020, Z-1863-2020, Z-1881-2020 and 12 more
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
- Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
- and 16 more product lines
Terminated Class II Medical devices
- Recall started
- 18 April 2019
- Terminated
- 28 July 2025
- Reason
- Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1640-2019, Z-1506-2019, Z-1638-2019, Z-1509-2019, Z-1564-2019, Z-1651-2019, Z-1591-2019, Z-1587-2019, Z-1663-2019, Z-1532-2019, Z-1643-2019, Z-1585-2019 and 171 more
- Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01
- Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060
- Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01
- Maquet Getinge-BEQ-TOP 22701 Material: 701050790
- Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867
- Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 701054874R01
- Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168
- Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577
- and 175 more product lines
Terminated Class II Medical devices
- Recall started
- 24 January 2019
- Terminated
- 13 July 2020
- Reason
- Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
- Distribution
- Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0983-2019
- AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.