Medtronic Perfusion Systems: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Recall Summary Medtronic is recalling its DLP One-Piece Pediatric Arterial Cannula (Product Number 77010), which is a tube used during heart-lung bypass surgery in children. The company received two reports of loose foreign material found inside the device that contained trace amounts of blood. This recall affects products distributed nationwide across the United States.
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; 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/4c8804a8-c9c9-4056-be6c-c4a35e3f03b8