Flexor G08867Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002088672), received between Jan 31, 2017 and Mar 4, 2021 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2021Material Separation; Unraveled Material; Material Separation; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2021. ANTEGRADE ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY WITH AN UNSPECIFIED 5 FRENCH STIFF MICROPUNCTURE DEVICE FOR ANGIOPLASTY OF THE LEG, TARGETING THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY AND A DISTAL SURGICAL GRAFT ANASTOMOSIS. THE ACCESS SITE WAS HEAVILY SCARRED. A 0.035-INCH STIFF WIRE WAS PLACED, AND THE TRACT WAS DILATED TO 8-FRENCH WITH DILATORS PRIOR TO PLACING THE COMPLAINT DEVICE. OTHER MANUFACTURERS¿ BALLOONS, 0.035-INCH WIRE GUIDE, AND CATHETER WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. THE SHEATH, WHICH HAD BEEN IN PLACE FOR NINETY MINUTES, SEPARATED INTO TWO PIECES IN THE MIDDLE OF THE DEVICE UPON REMOVAL, AT THE SUCCESSFUL CONCLUSION OF THE PROCEDURE. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE DEVICE AND NO OTHER DEVICES WERE IN THE LUMEN OF THE SHEATH AT THE TIME OF SEPARATION. RESISTANCE WAS REPORTED UPON INSERTION AND/OR REMOVAL DUE TO THE SCARRED GROIN. AFTER SURGICAL REMOVAL OF THE RETAINED SHEATH, THE PATIENT REQUIRED AN UNPLANNED OVERNIGHT STAY IN THE HOSPITAL AND WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11415420 ↗
• MalfunctionSep 12, 2018Material Separation; Material Separation

  IT WAS REPORTED, A FLEXOR INTRODUCER SHEATH WAS NOTED TO HAVE BROKEN APPROXIMATELY 5 TO 10 CM FROM THE HUB. THIS EVENT OCCURRED AS THE COMPLAINT DEVICE WAS BEING PULLED BACK AFTER PUNCTURING OF THE COMMON FEMORAL ARTERY. ACCORDING TO THE COMPLAINANT, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7870304 ↗
• InjuryMay 3, 2018Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7483742 ↗
• MalfunctionMay 12, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE WHILE USING A FLEXOR INTRODUCER SHEATH, THE SHEATH PULLED APART FROM THE CHECK FLO VALVE. IT WAS ALSO REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS DUE TO THIS OCCURRENCE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6564997 ↗
• MalfunctionApr 26, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A PERIPHERAL INTERVENTION, THE VALVE / SIDE PORT OF A FLEXOR INTRODUCER SHEATH LEAKED EXCESSIVELY WHEN PLACED AT THE FEMORAL SITE. IT LEAKED WITH EACH PULSE. A NEW SHEATH WAS USED TO COMPLETE THE CASE. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED DUE TO THE BLOOD LOSS.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 6521729 ↗
• MalfunctionJan 31, 2017Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  A PTA SFA RIGHT SIDE, WITH IN STENT STENOSIS WAS BEING CONDUCTED ON THE MALE PATIENT WITH PRE-EXISTING CONDITION OF VASCULAR DISEASE. INFORMATION WAS PROVIDED THAT THE PATIENT HAS A LOT OF SCAR TISSUE IN THE LEFT GROIN. THE PHYSICIAN USED A CROSS OVER APPROACH, PUNCTURE OF LEFT CFA WITH A COOK CATHETER ACCESS PERCUTANEOUS ENTRY NEEDLE, FOLLOWED BY PLACEMENT OF AMPLATZ WIRE. DIFFICULTIES WERE EXPERIENCED WITH PLACEMENT OF THE KCFW SHEATH AS SCAR TISSUE RESULTED IN A LOT OF FRICTION. THE PHYSICIAN DECIDED TO EXCHANGE THE 30CM FLEXOR SHEATH FOR A 45CM FLEXOR SHEATH AND ATTEMPTED TO REMOVE THE KCFW 30CM SHEATH BY PULLING THE VALVE. IT WAS REPORTED THAT THERE WAS FRICTION AND SUDDENLY THE CHECK-FLO VALVE SEPARATED FROM THE FLEXOR SHEATH; RESULTING IN BLEEDING. THE SHEATH WAS EXCHANGED QUICKLY FOR THE 45CM FLEXOR. IT WAS REPORTED THAT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Blood Loss

  MAUDE report 6289418 ↗