Medtronic Perfusion Systems recalls Octopus 4 Tissue Stabilizer

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.

Octopus 4 Tissue Stabilizer, Model 29400

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 RS.CFQFCA@medtronic.com. 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.

• FDA enforcement recordOfficial FDA database entry for Z-2577-2026
• FDA device classification · MWSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.4500The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medtronic Perfusion SystemsSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.