Wayne, NJ, United States
Maquet Cardiovascular Us Sales, Llc recalls
15 recalls recorded since 2018, most recently on 20 November 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls15
Ongoing (FDA)0
Terminated or completed15
Class I (FDA)2
Terminated Class II Medical devices
- Recall started
- 20 November 2020
- Terminated
- 7 November 2024
- Reason
- The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Ko
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0632-2021, Z-0633-2021
- HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation
- HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for c
Terminated Class II Medical devices
- Recall started
- 30 September 2020
- Terminated
- 25 May 2023
- Reason
- The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit board (PCB) where as the standard requires a creepage distance of 4 mm.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, IA, MD, NC, PA, TX, WA, WI and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Italy, Jordan, Malaysia,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0443-2021
- Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous moni
Terminated Class II Medical devices
- Recall started
- 24 September 2020
- Terminated
- 28 February 2023
- Reason
- Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still connected to the main socket (power source), there is a risk that a user or third person may suffer an electric shock when coming in contact with the exposed electronic components
- Distribution
- Worldwide distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, FINLAND, FRANCE GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, KENYA, KOREA, K
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0132-2021, Z-0133-2021
- Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 1
- Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143302F0 (US) Part 143302B0 (O
Terminated Class III Medical devices
- Recall started
- 7 August 2020
- Terminated
- 14 January 2021
- Reason
- Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of ME, NY, NV, OH, TX, VA, WA and the countries of China, Colombia, India, Italy, Mexico, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Arabic Emirates, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2957-2020
- Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorp
Terminated Class II Medical devices
- Recall started
- 18 June 2020
- Terminated
- 30 December 2022
- Reason
- Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of OH, PA, SC, CT and the countries of Germany, Spain, France, United Kingdom, Italy, United Arab Emirates, Mexico, Canada, Croatia, Georgia, Poland, Slovakia, Thailand, and Vietnam.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2780-2020
- Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenat
Terminated Class II Medical devices
- Recall started
- 20 February 2020
- Terminated
- 18 January 2022
- Reason
- A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.
- Distribution
- Domestic distribution only to the following states: AL AZ CA CT FL GA IL MA MI NC NH NM NY OH OK TN TX VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1603-2020
- Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Terminated Class II Medical devices
- Recall started
- 10 February 2020
- Terminated
- 13 September 2023
- Reason
- Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water
- Distribution
- Nationwide Foreign: Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Iran, Ireland, Israel, Italy, Japan, Kenya, Lithuania, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, Sou
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1475-2020
- Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
Terminated Class III Medical devices
- Recall started
- 16 January 2020
- Terminated
- 23 October 2023
- Reason
- Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
- Distribution
- U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1390-2020, Z-1391-2020
- Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to cle
- Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to cle
Terminated Class II Medical devices
- Recall started
- 3 December 2019
- Terminated
- 18 September 2020
- Reason
- A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
- Distribution
- The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0678-2020
- Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Terminated Class II Medical devices
- Recall started
- 11 July 2019
- Terminated
- 11 December 2020
- Reason
- The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.
- Distribution
- The products were distributed to the following US states: AR, CA, FL, GA, IA, IL, IN, KY, NC, NE, NM, NV, NY, OH, OR, TN, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2149-2019
- Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
Terminated Class II Medical devices
- Recall started
- 28 May 2019
- Terminated
- 10 July 2023
- Reason
- Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
- Distribution
- Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULG
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1864-2019, Z-1860-2019, Z-1857-2019, Z-1856-2019, Z-1858-2019, Z-1855-2019, Z-1859-2019, Z-1852-2019, Z-1853-2019, Z-1861-2019, Z-1863-2019, Z-1854-2019 and 1 more
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
- and 5 more product lines
Terminated Class II Medical devices
- Recall started
- 20 May 2019
- Terminated
- 15 December 2023
- Reason
- Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.
- Distribution
- Worldwide Distribution - US Nationwide GA, IL, IN, MI, NC, OR, PA, VA Foreign: Australia, Canada, China, France, Germany, India, Japan, Korea, Netherlands, Saudi Arabia, South Africa, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1777-2019, Z-1778-2019
- Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reus
- Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable it
Terminated Class II Medical devices
- Recall started
- 6 May 2019
- Terminated
- 6 July 2022
- Reason
- User may suffer an electric shock when coming in contact with the exposed electronic components
- Distribution
- Worldwide - US Nationwide Distribution Foreign: ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BOLIVIA BOTSWANA BOSNIA AND HERZEGOVINA BRAZIL BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1734-2019
- GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operat
Terminated Class I Medical devices
- Recall started
- 8 February 2019
- Terminated
- 14 May 2020
- Reason
- Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.
- Distribution
- US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0986-2019
- Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Terminated Class I Medical devices
- Recall started
- 25 October 2018
- Terminated
- 5 June 2020
- Reason
- There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, IA, LA, NC, and TX and countries of: Canada, Argentina, Brazil, Chile, Colombia, Mexico, Uruguay, United Arab Emirates, Belgium, Switzerland, Germany, Egypt, Spain, France, United Kingdom, Ireland, Italy, Lebanon, Netherlands, Pakist
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0436-2019, Z-0437-2019
- QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal cir
- QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circul
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.