Medtronic Perfusion Systems: Stabilizer, Heart
Recall Summary Medtronic is recalling the Octopus Evolution Tissue Stabilizer (Model TS2000), a medical device used during heart surgery, due to a manufacturing error where the tubing was assembled backwards—the short tube was placed on the bottom instead of the top. This recall affects units distributed nationwide across all U.S. states and territories. The device is classified as a serious safety issue requiring immediate attention.
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Octopus Evolution Tissue Stabilizer, Model TS2000
- 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/9c924315-8841-4834-806d-d1b66c7fa1b2