Flexor G30120Recalls & 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
- 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 00827002301207), received between Oct 19, 2016 and Dec 5, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Material Frayed1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2019Material Frayed; Material Frayed
AS REPORTED, DURING A COIL EMBOLIZATION PROCEDURE, THE TIP OF A FLEXOR ANSEL GUIDING SHEATH FRAYED. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY WITH ANOTHER MANUFACTURER'S 5 FRENCH INTRODUCER SET. THE 5 FRENCH SHEATH WAS REMOVED AND THE USER ATTEMPTED TO INSERT THE COMPLAINT DEVICE; HOWEVER, THE DILATOR WAS NOT ABLE TO BE INSERTED INTO THE PATIENT'S BODY. AS THE USER REMOVED THE DEVICE, A FRAY WAS FOUND AT THE TIP OF THE SHEATH. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY OR THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES AS A RESULT OF THE EVENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9416627 ↗MalfunctionOct 19, 2016Fluid/Blood Leak; Fluid/Blood Leak
A FEMALE PATIENT OF UNKNOWN AGE UNDERWENT A PROCEDURE FOR COIL EMBOLIZATION IN THE RENAL ARTERY. THE DEVICE WAS ADVANCED FROM THE LEFT COMMON FEMORAL ARTERY TO THE RENAL ARTERY. WHEN ATTEMPTING TO PERFORM THE EMBOLIZATION, BLOOD LEAKED FROM THE TUOHY-BORST VALVE SINCE THE VALVE COULD NOT BE CLOSED AFTER THE USER TIGHTENED THE TUOHY-BORST VALVE. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6039442 ↗
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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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