Z-2575-2026Class II

Octopus Evolution Tissue Stabilizer, Model TS2000

Name: Z-2575-2026 Octopus Evolution Tissue Stabilizer, Model TS2000
Creator: Medtronic Perfusion Systems
Published: 2026-05-12
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2026-05-12 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Perfusion Systems began a recall of Octopus Evolution Tissue Stabilizer, Model TS2000 on 2026-05-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2575-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-12
Posted: 2026-06-24
Recalling firm: Medtronic Perfusion Systems
Product: Octopus Evolution Tissue Stabilizer, Model TS2000
Product code: MWS Stabilizer, Heart
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
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.
Quantity in commerce: 134 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2575-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2575-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-24
Z-2576-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-24
Z-2577-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-24

Product code MWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)