Atrium Medical recalls
15 official recalls and safety alerts involving Atrium Medical since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Atrium Medical or the relevant agency.
- 2026-09-16
USAtrium Medical Corporation recalls Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4.…
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- 2024-10-16
- US
Atrium Medical Corporation recalls iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
FDA · DeviceAtrium Medical CorporationUS Nationwide distribution in the states of FL, MA, MI, OH, WA.Official notice → - 2024-06-12
- US
Atrium Medical Corporation recalls ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide including Puerto Rico, and the…Official notice → - 2024-01-03
- US
Atrium Medical Corporation recalls Atrium Oasis Drain Single W / AC, Part No. 3600-100
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.…
FDA · DeviceAtrium Medical CorporationDomestic distribution nationwide. No foreign distribution.Official notice → - 2023-12-13
- US
Atrium Medical Corporation recalls Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
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.
- US
Atrium Medical Corporation recalls Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
FDA · DeviceAtrium Medical CorporationUS: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TXOfficial notice → - 2023-11-22
- US
Atrium Medical Corporation recalls Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
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…
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - US
Atrium Medical Corporation recalls Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac…
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
FDA · DeviceAtrium Medical CorporationForeign: Australia, Belgium, Canada, France, Germany, Greece, Malta,…Official notice → - 2023-04-05
- US
Atrium Medical Corporation recalls Express Mini 500 Dry Seal Chest Drain, Part Number 16400
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…
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide and the countries of United Arab…Official notice → - 2022-11-23
- US
Atrium Medical Corporation recalls Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
FDA · DeviceAtrium Medical CorporationUS Nationwide distribution in the state of VA.Official notice → - 2022-07-06
- US
Atrium Medical Corporation recalls Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or…
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…
- 2022-05-25
- US
Atrium Medical Corporation recalls Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328…
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…
FDA · DeviceAtrium Medical CorporationForeign: Australia Austria Bahrain Belgium Bosnia-Herzegovina Brazil Bulgaria…Official notice → - 2021-12-01
- US
Atrium Medical Corporation recalls The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds…
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
FDA · DeviceAtrium Medical CorporationUS Nationwide Distribution Foreign: Bahrain Belgium Brunei Darussalam Canada…Official notice → - 2021-10-06
- US
Atrium Medical Corporation recalls Atrium Pneumostat Chest Drain Valve, Part Number 16100
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.
FDA · DeviceAtrium Medical CorporationDomestic distribution nationwide. Foreign distribution worldwide.Official notice → - US
Atrium Medical Corporation recalls Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular…
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide distribution in the state of Florida…Official notice →