Flexor G08246Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002082465), received between Aug 11, 2020 and Dec 12, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE HUB SEPARATED ON A FLEXOR INTRODUCER SHEATH. NEAR THE END OF THE PROCEDURE, THE PHYSICIAN WITHDREW THE SHEATH BY THE HUB AND THE HUB CAME OFF, CAUSING BLEEDING OUT THE PROXIMAL END. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL. THE SHEATH WAS REMOVED AND THE PROCEDURE COMPLETED. THE PATIENT IS REPORTEDLY DOING "FINE". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18313096 ↗
• InjuryAug 23, 2021Material Deformation; Material Deformation

  AS REPORTED, A FLEXOR INTRODUCER SHEATH WAS USED DURING A PROCEDURE INVOLVING PLACEMENT OF BILATERAL ILIAC STENTS AND SHOCKWAVE BALLOONING FOR BILATERAL ILIAC OCCLUSION. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY, AND THE ANATOMY WAS CALCIFIED. ANOTHER MANUFACTURER'S SHOCKWAVE BALLOON WAS ADVANCED THROUGH THE COOK SHEATH OVER AN UNSPECIFIED WIRE GUIDE. AFTER INFLATION AND DEFLATION OF THE BALLOON, IT WAS REMOVED THROUGH THE SHEATH; HOWEVER, THE BALLOON WAS NOTED TO HAVE SEPARATED FROM THE SHOCKWAVE CATHETER. THE SHEATH WAS REMOVED FROM THE PATIENT WITHOUT THE DILATOR. AFTER REMOVAL, THE END OF THE SHEATH WAS DESCRIBED AS FLARED AND ROUGH. THE PATIENT WAS TAKEN TO SURGERY FOR REMOVAL OF THE OTHER MANUFACTURER'S BALLOON FRAGMENTS. THE COOK SHEATH DID NOT SEPARATE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12352890 ↗
• MalfunctionMay 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768507 ↗
• MalfunctionAug 25, 2020Material Separation; Material Separation

  IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE FLEXOR INTRODUCER SHEATH & FLEXOR ANSEL GUIDING SHEATH WERE UTILIZED WITH COMPLICATIONS. ACCORDING TO THE INITIAL REPORTER, BOTH DEVICES WERE USED AT THE SAME ACCESS SITE, WHICH WAS NOTED TO HAVE HEAVY CALCIFICATION. WHILE ATTEMPTING TO REMOVE THE OTHER MANUFACTURER'S DEVICE, THE HUB OF ONE OF THE COOK SHEATH'S SEPARATED. DURING THE SAME PROCEDURE, THE OTHER COOK SHEATH UNCOILED; HOWEVER, THE ATTENDING NURSE WAS UNABLE TO IDENTIFIED AT WHAT POINT DURING THE PROCEDURE THIS OCCURRED. ADDITIONALLY, THE INITIAL REPORTER COULD NOT CONFIRM WHAT SHEATH EXHIBITED WHICH FAILURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10450122 ↗
• MalfunctionAug 11, 2020Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10390950 ↗