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OCTOPUS® TSMICS1 (UDI 00643169668959)Recalls & reported problems

Medtronic, Inc. · STABILIZER TSMICS1 OCTOPUS NUVO 26L · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169668959), received between Jun 12, 2023 and Jun 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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.

Most reported problems

Device problems

  • Material Separation1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 12, 2023Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN OCTOPUS NUVO TISSUE STABILIZER, THE STABILIZER HEADLINK COULDN'T BE FIXED IN THE SHAFT PROPERLY. IT FELL OFF WHEN ATTACHED TO THE TISSUE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17105471 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.