Medtronic Perfusion Systems: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Recall Summary Medtronic is recalling its Bio-Medicus Adult Cannula Kit (Product Number 96530-115), a device used in cardiopulmonary bypass procedures, due to reports of loose foreign material containing trace amounts of blood found inside the product. The recall affects units distributed nationwide across the United States. This is classified as a Class II recall, meaning the product could cause serious health problems but is unlikely to cause death.
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
- Reason
- Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-25
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/9e49fc5e-c014-43a3-8ca7-4a497d9c01c8