Flexor G07856Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002078567), received between Jun 5, 2018 and Nov 12, 2019 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE TO PLACE A NEPHROSTOMY DRAIN, A FLEXOR INTRODUCER SHEATH HUB SEPARATED FROM THE SHEATH UPON REMOVAL OF THE DEVICE, WHICH HAD BEEN IN PLACE FOR FIVE MINUTES. THE SHEATH WAS PLACED IN THE KIDNEY AND AN UNKNOWN 0.035 INCH WIRE WAS IN THE LUMEN OF THE SHEATH AT THE TIME OF HUB SEPARATION, AT WHICH POINT THE WIRE CAME OUT OF THE SHEATH. THE PATIENT'S ANATOMY WAS REPORTEDLY SCARRED; HOWEVER, RESISTANCE WAS NOT REPORTED. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE DEVICE, WHICH WAS PULLED FROM THE PATIENT BY THE HUB. THE PATIENT DID NOT EXPERIENCE ANY BLOOD LOSS, AS THE SHEATH WAS IN THE KIDNEY INSTEAD OF THE VASCULAR SYSTEM. THE NEPHROSTOMY DRAIN WAS SUCCESSFULLY PLACED IN THE PATIENT. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9310929 ↗
• InjuryJun 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, DURING ENDOVASCULAR ANEURYSM REPAIR FOR AN AORTIC ANEURYSM, THE PHYSICIAN NOTED BLOOD LOSS AFTER INSERTING THE FLEXOR INTRODUCER SHEATH INTO THE EXTERNAL ILIAC ARTERY. REPORTEDLY, ACCESS WAS GAINED FROM THE LEFT EXTERNAL ILIAC ARTERY USING AN IPSALATERAL APPROACH VIA A MICROPUNCTURE SET AND PERCLOSE DEVICE (ABBOTT). PATIENT'S ANATOMY UPON INSERTION WAS MINIMALLY TORTUOUS. THE INITIAL PERCLOSE DEVICE (ABBOTT) WAS REMOVED AND THE 8FR FLEXOR INTRODUCER SHEATH WAS PLACED USING A BENTSON WIRE (COOK MEDICAL). RESISTANCE WAS FELT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE COMPLAINT DEVICE OVER THE WIRE GUIDE. THE PHYSICIAN HELD SIGNIFICANT PRESSURE ON THE PATIENT'S ABDOMEN AND CONTINUED TO PULL BACK ON THE COMPLAINT DEVICE. THE HUB SEPARATED, LEAVING THE SHEATH TUBING AND WIRE GUIDE IN THE PATIENT'S ARTERY. THE PATIENT BEGAN LOSING BLOOD THROUGH THE 8FR FLEXOR INTRODUCER SHEATH LUMEN, AND MANUAL PRESSURE WAS HELD AT THE ACCESS SITE. A CODA BALLOON CATHETER (COOK MEDICAL) WAS PLACED, VIA ANOTHER ACCESS SITE, TO SUCCESSFULLY CONTROL THE BLEEDING. A CUT-DOWN PROCEDURE WAS THEN PERFORMED TO COMPLETE THE AORTIC ANEURYSM REPAIR PROCEDURE AND RETRIEVE THE SHEATH AND WIRE GUIDE W

  Patient problems: Blood Loss; No Code Available

  MAUDE report 7570454 ↗