Medtronic Perfusion Systems: Stabilizer, Heart
Recall Summary Medtronic is recalling the Octopus Evolution AS Tissue Stabilizer (Model TS2500), a heart surgery device distributed nationwide, because the tubing was assembled backwards during manufacturing—the short tube was attached to the bottom instead of the top. This is a Class I recall, the most serious classification. The device was distributed across all U.S. states and territories.
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Octopus Evolution AS Tissue Stabilizer, Model TS2500
- 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/dfd5644e-13a3-4a1f-9a33-b17fac2fb3ff