Medtronic Perfusion Systems: Stabilizer, Heart
Recall Summary Medtronic is recalling the Octopus 4 Tissue Stabilizer (Model 29400), a heart surgery device, because the tubing was assembled incorrectly during manufacturing—the short tube was attached to the bottom and the long tube to the top, opposite of how it should be. This recall affects units distributed nationwide across all U.S. states. The device is used during heart surgery procedures to stabilize tissue during cardiac operations.
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Octopus 4 Tissue Stabilizer, Model 29400
- Reason
- During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-12
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/9b2b1105-c490-41bd-9a36-0a23ab338fb7