Maquet Cardiopulmonary Gmbh: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Maquet Cardiopulmonary is recalling certain Percutaneous Insertion Kits and Guidewires used in cardiopulmonary bypass procedures because the packaging may not reliably keep the sterile barrier intact. The recall affects products distributed nationwide in the US and in multiple countries worldwide. This is classified as a Class II recall.
- Recalling firm
- Maquet Cardiopulmonary Gmbh
- Product
- Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
- Reason
- The packaging may not consistently maintain sterile barrier integrity.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-31
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/bea05b70-9b3a-46e0-a8d2-863a9a415e91