FDA Recall Open, Classified

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

Recall: Z-1473-2026 · Initiated January 13, 2026

Recall

Recall Number
Z-1473-2026
Event Number
98354
Firm
Medtronic Perfusion Systems
FEI Number
1000116158
Product Code
MWS
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
January 13, 2026
Posted
February 26, 2026
Address
7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

Description

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

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.

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 Customer Confirmation Form and email to [email protected]. 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.

Distribution

US Nationwide distribution in the states of FL and IN.

Quantity

2 units