Flexor G32216Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002322165), received between Apr 9, 2015 and Jan 3, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRANS-JUGULAR RENAL BIOPSY, A FLEXOR BALKIN GUIDING SHEATH SEPARATED AT THE HUB. ACCESS WAS GAINED FROM THE INTERNAL JUGULAR VEIN. THE SHEATH AND AN UNKNOWN BIOPSY NEEDLE WERE INTRODUCED. IT WAS REPORTED THAT THE PHYSICIAN REALIZED THAT THE BIOPSY NEEDLE WOULD NOT REACH THE BIOPSY SITE; THEREFORE, THE PROCEDURE WAS ABORTED AND THE NEEDLE AND SHEATH WERE REMOVED. AT THAT POINT, THE HUB OF THE SHEATH SEPARATED FROM THE SHAFT. NO OTHER DEVICES WERE IN THE LUMEN OF THE SHEATH AT THE TIME OF REMOVAL. THE PATIENT'S ANATOMY WAS NOT UNUSUAL. THE SHAFT WAS REMOVED WITH AN UNKNOWN SNARE; REQUIRING THE PHYSICIAN TO OBTAIN GROIN ACCESS. SNARING OF THE DEVICE WAS REPORTED TO ADD THREE HOURS TO THE PROCEDURE. NO PORTION OF THE DEVICE REMAINED IN THE BODY AFTER THE SNARING PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT AFTER THE PROCEDURE. OTHER ADVERSE EFFECTS HAVE NOT BEEN REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Code Available

  MAUDE report 8214275 ↗
• InjuryApr 28, 2016Material Separation; Material Separation

  DURING A CROSSOVER PROCEDURE VIA FEMORAL ACCESS ON A MALE PATIENT TO INSERT A LYSIS CATHETER AFTER TREATMENT BY PTA BALLOON AND STENT, THE SHEATH RIPPED UPON REMOVAL. SOME PIECES HAD TO BE REMOVED SURGICALLY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS NOR REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5616961 ↗
• MalfunctionApr 9, 2015Leak/Splash

  DURING A APOD PROCEDURE ON THE (B)(6) YEAR OLD FEMALE PATIENT, AFTER THE STENT REPLACEMENT, THE DOCTOR REMOVED THE FLEXOR SHEATH. WHEN HE PULLED THE SHEATH, IT BEGAN TO LEAK FROM THE HUB. HE SPENT MUCH TIME TRYING TO STOP BLOOD LOSS. FINALLY HE WAS ABLE TO FINISH THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS TO THIS OCCURRENCE.

  Patient problems: Blood Loss

  MAUDE report 4687641 ↗