Recall Z-1473-2026

Reason for recall

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.

FDA-determined cause: Under Investigation by firm

Action taken

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. 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