Flexor G29995Recalls & reported problems
Cook Incorporated · Flexor, Tuohy-Borst Side-Arm Introducer Ansel Modification · Class 2
All models of Flexor (134)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002299955), received between Nov 20, 2017 and May 6, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Material Frayed1
- Material Separation1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF A FLEXOR ANSEL GUIDING SHEATH¿S DILATOR "CRACKED". THE DEVICE PACKAGE WAS NOT DAMAGED. RESISTANCE WAS ENCOUNTERED UPON ADVANCEMENT OF THE DEVICE INTO THE FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED; HOWEVER, THE DEVICE WAS ADVANCED THROUGH A PREVIOUSLY PLACED VASCULAR CLOSURE DEVICE. THE DEVICE WAS REMOVED AND A CRACK IN THE DILATOR TIP WAS FOUND. THE CRACK WAS NOT SHARP. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. 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
MAUDE report 19253425 ↗MalfunctionMay 10, 2021Material Frayed; Material Frayed
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11803153 ↗MalfunctionJun 26, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10201339 ↗MalfunctionNov 20, 2017Material Separation; Material Separation
IT WAS REPORTED THAT DURING AN ABDOMEN WITH RUNOFF PROCEDURE IN WHICH ACCESS WAS GAINED VIA A CONTRALATERAL APPROACH, THE FLEXOR ANSEL GUIDING SHEATH SNAPPED IN TWO WHEN PULLING IT OUT OF THE PATIENT'S FEMORAL ARTERY. BOTH PIECES OF THE SHEATH WERE SUCCESSFULLY REMOVED FROM THE PATIENT'S ANATOMY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7045715 ↗
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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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