Flexor G13338Recalls & reported problems
Cook Incorporated · Flexor, Tuohy-Borst Side-Arm Introducer Shuttle, - SL · Class 2
All models of Flexor (134)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002133389), received between Jun 22, 2023 and May 1, 2024 — classified as 3 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
- Leak/Splash1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2024Unraveled Material; Unraveled Material
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 19221983 ↗MalfunctionAug 11, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
ADDITIONAL INFORMATION WAS RECEIVED 30AUG2023. THE PROCEDURE INVOLVED TREATMENT ('OPENING') OF A LOWER EXTREMITY ARTERIAL OCCLUSION WITHIN THE SUPERFICIAL FEMORAL ARTERY. THE TIP DAMAGE WAS OBSERVED WHILE FLUSHING THE DEVICE, PRIOR TO USE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17511213 ↗MalfunctionJun 22, 2023Leak/Splash; Leak/Splash
AS REPORTED, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH'S THREE-WAY STOPCOCK LEAKED WHILE FLUSHING THE DEVICE PRIOR TO THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 17186486 ↗
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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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