OCTOPUS recallZ-2577-2026 · Medtronic Perfusion Systems · initiated May 12, 2026
Open, Classified
Is my device affected?
- 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.
- 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.
- 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 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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2577-2026
- Status
- Open, Classified
- Initiated by the company
- May 12, 2026
- Posted by the FDA
- Jun 24, 2026
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 590 units
- Product code
- MWS
- Distribution
- Worldwide - US Nationwide distribution.
Product description
Octopus 4 Tissue Stabilizer, Model 29400
Code information (models, lots, serial numbers)
UDI-DI: 00763000543679; Serial Numbers: 0231266463 0231468923 0231478249 0231478253 0231478260 0231651627 0231651634 0231651636 0231651637 0231651638 0231651639 0231651641 0231651642
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OCTOPUS® 29400Medtronic, Inc. · Stabilizer, heart1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98966).
- Z-2575-2026 · Open, ClassifiedOctopus Evolution Tissue Stabilizer, Model TS2000
- Z-2576-2026 · Open, ClassifiedOctopus Evolution AS Tissue Stabilizer, Model TS2500
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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