Flexor G56235Recalls & reported problems
Cook Incorporated · Flexor, Check-Flo, Introducer Ansel 1 Modification - with High-Flex Dilator and Hydrophilic Coating · Class 2
All models of Flexor (134)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002562356), received between Jan 28, 2021 and Feb 17, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING AN UNSPECIFIED VETERINARY PROCEDURE ON AN UNKNOWN ANIMAL SPECIES, THE HUB SEPARATED FROM A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH'S DILATOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13549624 ↗InjuryJan 28, 2021Material Separation; Material Separation
AS REPORTED, DURING A PERIPHERAL ANGIOGRAM, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED. ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY. ANOTHER UNKNOWN MANUFACTURER'S BALLOON WAS USED THROUGH THE COOK SHEATH. THE UNKNOWN BALLOON WOULD NOT DEFLATE, SO THE USER ATTEMPTED TO POP THE BALLOON USING A "FEW" UNKNOWN WIRE GUIDES; HOWEVER, THIS WAS UNSUCCESSFUL. THE USER FORCEFULLY PULLED THE BALLOON THROUGH THE SHEATH, AT WHICH POINT THE BALLOON CATHETER BROKE AND THE SHEATH MATERIAL SEPARATED AND UNCOILED. A SNARE WAS USED TO REMOVE THE SEPARATED PORTION OF THE SHEATH FROM THE PATIENT. IT IS BELIEVED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER SHEATH. THERE WAS NO HARM TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available
MAUDE report 11245982 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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