Flexor G10634Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002106345), received between May 12, 2017 and Sep 28, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

• MalfunctionSep 28, 2020Unsealed Device Packaging; Unsealed Device Packaging

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 10592317 ↗
• MalfunctionAug 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, PRIOR TO A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE FOR SUPERFICIAL FEMORAL STENOSIS, A FLEXOR BALKIN GUIDING SHEATH LEAKED AT THE HUB. THE LEAK WAS OBSERVED UPON THE FIRST FLUSH OF THE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 Consequences Or Impact To Patient

  MAUDE report 8898378 ↗
• MalfunctionMay 18, 2017Fracture

  THE INFORMATION RECEIVED INDICATED THAT THE TIP OF THE SHEATH WAS "IRREGULAR FRACTURE" PRIOR TO USE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6574998 ↗
• MalfunctionMay 17, 2017Failure to Advance

  IT WAS REPORTED THAT DURING A VASCULAR EMBOLIZATION PROCEDURE ACCESSED THROUGH THE LEG, THE PHYSICIAN WAS UNABLE TO PASS THE AMPLATZER PLUG THROUGH THE TUOHY. UNSCREWED THE TUOHY FROM BACK END OF SHEATH AND INPUT THE PLUG WITH NO VALVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6572954 ↗
• MalfunctionMay 12, 2017Bent; Failure to Advance

  IT WAS REPORTED THAT DURING A LOWER EXTREMITY ANGIOGRAPHY OF THE ILIAC ARTERY, THE TIP OF THE DILATOR WAS BENT AND THE GUIDE WIRE FAILED TO GO THROUGH. A NEW SHEATH WAS USED TO FINISH THE PROCEDURE. UPON FURTHER REVIEW OF THE PRODUCT ISSUE, IT WAS NOTED THAT THE DILATOR TIP WAS SPLIT WHICH COULD CAUSE OR CONTRIBUTE TO VESSEL DAMAGE IF IT WERE TO RECUR. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6562951 ↗