Merrimack, NH, United States
Atrium Medical Corporation recalls
17 recalls recorded since 2018, most recently on 7 August 2026. 14 are listed as ongoing. Status and classification are as published by the FDA.
Recalls17
Ongoing (FDA)14
Terminated or completed3
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 7 August 2026
- Reason
- An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3111-2026, Z-3113-2026, Z-3112-2026
- Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
- Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
- Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
Ongoing Class II Medical devices
- Recall started
- 9 September 2024
- Reason
- There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
- Distribution
- US Nationwide distribution in the states of FL, MA, MI, OH, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0024-2025
- iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Ongoing Class II Medical devices
- Recall started
- 3 May 2024
- Reason
- Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
- Distribution
- Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, P
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1989-2024, Z-1986-2024, Z-1960-2024, Z-1954-2024, Z-2012-2024, Z-1987-2024, Z-1978-2024, Z-2009-2024, Z-2016-2024, Z-1977-2024, Z-2017-2024, Z-2010-2024 and 56 more
- ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
- ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
- ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
- ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
- FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
- ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
- ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
- FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
- and 60 more product lines
Ongoing Class II Medical devices
- Recall started
- 1 November 2023
- Reason
- A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.
- Distribution
- Domestic distribution nationwide. No foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0621-2024
- Atrium Oasis Drain Single W / AC, Part No. 3600-100
Ongoing Class II Medical devices
- Recall started
- 29 September 2023
- Reason
- A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
- Distribution
- US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0484-2024
- Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Ongoing Class II Medical devices
- Recall started
- 21 September 2023
- Reason
- Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
- Distribution
- Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0291-2024
- Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered s
Ongoing Class II Medical devices
- Recall started
- 18 September 2023
- Reason
- Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Czech Republic Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, Indonesia, Ireland, Israel, Italy, Jordan, Korea, Republic of Kuw
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0318-2024, Z-0316-2024, Z-0317-2024
- Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
- Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DR
- Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
Ongoing Class II Medical devices
- Recall started
- 5 September 2023
- Reason
- Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
- Distribution
- US: VA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0486-2024, Z-0485-2024
- Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
- Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Ongoing Class II Medical devices
- Recall started
- 1 March 2023
- Reason
- The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.
- Distribution
- Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Colombia, Czech Republic, Germany, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Indonesia, Ireland, Israel, Iceland, Italy, Jordan, Sout
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1303-2023, Z-1302-2023
- Express Mini 500 Dry Seal Chest Drain, Part Number 16400
- Atrium Pneumostat Chest Drain Valve, Part Number 16100
Ongoing Class II Medical devices
- Recall started
- 18 October 2022
- Reason
- Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
- Distribution
- US Nationwide distribution in the state of VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0235-2023
- Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Ongoing Class II Medical devices
- Recall started
- 21 April 2022
- Reason
- Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed 21SEP2024 (2024-09-21), causing product being used for up to five (5) days past the true expiration date
- Distribution
- AZ IL KS LA MI NY OH OK TX VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1297-2022
- Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028
Ongoing Class I Medical devices
- Recall started
- 3 March 2022
- Reason
- Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional anesthesia and contrast which may impact patients' renal function. Potential harms include occlusion or embolism and associated response, with specific outcomes such as amputation, embolism, loss of organ function, organ infarction, or tissue infarction. ***Updated June 2023*** Additional surgical stress caused by prolonged interventional surgery has the potential to lead to myocardial infarction or death.
- Distribution
- Foreign: Australia Austria Bahrain Belgium Bosnia-Herzegovina Brazil Bulgaria Canada Chile Colombia Costa Rica Cyprus Czech Republic Denmark Ecuador Egypt El Salvador Estonia Finland France Germany Great Britain Greece Hong Kong Hungary Iceland Ireland, Republic of Israel
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1076-2022, Z-1077-2022
- Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342
- iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 85417 85418 85419 85420 85424 85440 85
Ongoing Class II Medical devices
- Recall started
- 22 October 2021
- Reason
- Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
- Distribution
- US Nationwide Distribution Foreign: Bahrain Belgium Brunei Darussalam Canada Colombia Ecuador Finland Italy Kuwait Libya Mauritius Mexico Netherlands Poland Portugal Russian Federation Saudi Arabia Spain United Arab Emirates United Kingdom of Great Britain and Northern Ireland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0307-2022
- The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from
Ongoing Class II Medical devices
- Recall started
- 26 August 2021
- Reason
- The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2592-2021
- Atrium Pneumostat Chest Drain Valve, Part Number 16100
Terminated Class II Medical devices
- Recall started
- 25 August 2021
- Terminated
- 10 April 2024
- Reason
- The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2589-2021
- Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Terminated Class II Medical devices
- Recall started
- 12 October 2018
- Terminated
- 12 May 2020
- Reason
- This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious hazard to the patient. A sterility breach could potentially lead to product contamination. The potentially affected device is used in contact with critical anatomical structures and deep into the body. If contaminated, the consequences for the patient could be severe. The severity of the possible clinical complications depends on the degree of contamination of the device, the microorganisms involved and the patient s risk factors. To date, Getinge/Atrium has not received any reports of patient injury related to this issue.
- Distribution
- Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0560-2019
- Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Terminated Class II Medical devices
- Recall started
- 22 November 2017
- Terminated
- 30 July 2018
- Reason
- An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.
- Distribution
- Internationally to Spain only.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0712-2018
- ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcem
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.