—#218440

Product

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

FDA product code: MWS — Stabilizer, Heart
Device class: Class 1
Medical specialty: Cardiovascular
Affected lot / code info: UDI-DI: 00763000543693; Lot Number: 0232837110

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. This form must be returned even if you do not have the affected product in your possession. " Please maintain a copy of this communication in your records. If you have any questions regarding this communication, please contact your Medtronic Field Representative.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: US Nationwide distribution in the states of FL and IN.

Timeline

Recall initiated: 2026-01-13
Posted by FDA: 2026-02-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218440. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.