FDA Recall Open, Classified

Octopus Evolution AS Tissue Stabilizer, Model TS2500

Recall: Z-2576-2026 · Initiated May 12, 2026

Recall

Recall Number
Z-2576-2026
Event Number
98966
Firm
Medtronic Perfusion Systems
FEI Number
1000116158
Product Code
MWS
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
May 12, 2026
Posted
June 24, 2026
Address
7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

Description

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.

Action

An URGENT: MEDICAL DEVICE RECALL notification letter dated 5/12/26 was sent to customers. Customer Actions: Medtronic requests that you take the following actions: " Review your inventory for lot numbers listed in Attachment A. " If you have unused inventory from the listed lot numbers, immediately quarantine and return the products 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 share this notification with others in your organization as appropriate. If product listed above has been forwarded to another facility, please notify the facility of this Medtronic Urgent Medical Device Recall. " Please maintain a copy of this communication in your records. If you have any questions regarding this communication, please contact Medtronic Field Representative.

Distribution

Worldwide - US Nationwide distribution.

Quantity

288 units