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