OCTOPUS® TS2500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169668904), received between Apr 20, 2022 and Jan 28, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 12, 2026Open, Classified

   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.

   Z-2576-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN OCTOPUS TISSUE STABILIZER, IT WAS REPORTED THAT THE STERILE BOX OF THE PRODUCT WAS ALREADY OPEN, SO THE CUSTOMER QUESTIONED THE STERILITY OF THE PRODUCT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE STERILE PACKAGE WAS NOT PROPERLY CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198624 ↗
• MalfunctionJan 19, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN OCTOPUS TISSUE STABILIZER, IT WAS REPORTED THAT WHEN RECEIVING GOODS FROM THE CARRIER'S FORWARDER FROM MEDTRONIC TO AN PHA. THE CUSTOMER OBSERVED THAT 01 BOX HAD DAMAGED PACKAGING, THE PRODUCT INSIDE HAD BLACK STAINS DUE TO DAMAGED OUTER SHELL. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PACKAGE IS INTACT, CUSTOMER KEPT THE DEFECTIVE PACKAGE AS IT WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108300 ↗
• MalfunctionApr 20, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS OCTOPUS TISSUE STABILIZER, THE CUSTOMER REPORTED THAT WHEN THEY TOOK THE DEVICE OUT OF IT'S PACKAGING, THEY NOTED THAT HEAD WAS SEPARATED FROM THE BODY. THE DEVICE WAS REPLACED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159179 ↗