Recall Z-1473-2026 ยท MWS Stabilizer, Heart
Medtronic Perfusion Systems
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
| Date | Feb 26, 2026 (initiated Jan 13, 2026) |
| Status | Open, Classified |
| Reason | During the manufacturing, 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. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter dated January 2026 was hand delivered to customers. Actions: Medtronic requests that you take the following actions: " Review your inventory for listed lot number. " If you have inventory from the listed lot number immediately quarantine and return it to Medtronic by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return and exchange or credit of this unit. Your Medtronic sales representative can assist you in the return of unit as necessary. " Complete the enclosed Custo |
| Quantity | 939 units |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.