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OCTOPUS recallZ-1473-2026 · Medtronic Perfusion Systems · initiated Jan 13, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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. 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

Recall details

Recall number
Z-1473-2026
Status
Open, Classified
Initiated by the company
Jan 13, 2026
Posted by the FDA
Feb 26, 2026
Recalling firm
Medtronic Perfusion Systems
Quantity
939 units
Product code
MWS
Distribution
US Nationwide. Global Distribution.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 00763000543693; Lot Number: 0232837110, Additional lots as of 5/22/26: 0231547054 0231591827 0231758880 0231758898 0231758932 0231792414 0231792421 0231912903 0232670901 0232709219 0232709254 0232744928 0232784925 0232784989 0232805458

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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