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TourniKwik™ 79011Recalls & reported problems

Medtronic, Inc. · TOURNIQUET 79011 TOURNIKWIK 6IN 40PK 17L · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20613994576471), received between Mar 4, 2025 and Mar 4, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Deformation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 4, 2025Material Deformation; Material Deformation

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE TOURNIKWIK TOURNIQUET SETS, THE CUSTOMER REPORTED THAT THE SNARES HAVE BEEN COMING PACKED IN SUCH A WAY THAT THEY ARE BENT AND CRIMPED AND HAVE BEEN DESCRIBED AS UNUSABLE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER DID NOT HAVE THE EXAMPLE FROM THE HOSPITAL BUT THE BENT/CRIMPED DEVICES ARE STILL COMING INTERMITTENTLY IN THE PACKS. THE CUSTOMER STATED THAT IT SEEMED LIKE WHERE THE DEVICES WERE POSITIONED WITHIN THE PACK MAKES THEM VULNERABLE TO BEING BENT. WHEN THEY ARE BENT OR CRIMPED LIKE THE ONE IN THE PICTURE THEY ARE UNUSABLE AS A SNARE. THE CRIMPS WERE OCCURRING IN THE SHAFT (RED PART) OF THE TOURNIKWIK.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21513112 ↗
  • MalfunctionMar 4, 2025Material Deformation; Material Deformation

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE TOURNIKWIK TOURNIQUET SETS, THE CUSTOMER REPORTED THAT THE SNARES HAVE BEEN COMING PACKED IN SUCH A WAY THAT THEY ARE BENT AND CRIMPED AND HAVE BEEN DESCRIBED AS UNUSABLE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER DID NOT HAVE THE EXAMPLE FROM THE HOSPITAL BUT THE BENT/CRIMPED DEVICES ARE STILL COMING INTERMITTENTLY IN THE PACKS. THE CUSTOMER STATED THAT IT SEEMED LIKE WHERE THE DEVICES WERE POSITIONED WITHIN THE PACK MAKES THEM VULNERABLE TO BEING BENT. WHEN THEY ARE BENT OR CRIMPED LIKE THE ONE IN THE PICTURE THEY ARE UNUSABLE AS A SNARE. THE CRIMPS WERE OCCURRING IN THE SHAFT (RED PART) OF THE TOURNIKWIK.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21513076 ↗

Other CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY devices

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