Flexor G29988Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002299887), received between Sep 19, 2018 and May 29, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (4 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. How this data works · Data updated Oct 13, 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.

• InjuryMay 29, 2025Unraveled Material; Unraveled Material

  AS REPORTED, DURING AN ANGIOGRAM OF THE LEG AND TREATMENT OF BELOW-THE-KNEE TIBIAL ARTERY DISEASE, A FLEXOR ANSEL GUIDING SHEATH UNRAVELED AND ¿CAME APART¿ IN THE PATIENT UPON REMOVAL OF THE DEVICE. CONTRALATERAL ACCESS WAS OBTAINED IN THE FEMORAL ARTERY TO TARGET THE TIBIAL ARTERY. THE ARTERIES, INCLUDING THE BIFURCATION, WERE REPORTEDLY CALCIFIED AND THE BIFURCATION WAS STEEP. RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE SHEATH. ANOTHER MANUFACTURER¿S WIRE AND ANOTHER MANUFACTURER¿S BALLOON WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. RESISTANCE WAS ENCOUNTERED UPON REMOVAL OF THE SHEATH, WITH THE DILATOR IN PLACE, AND THE SHEATH UNRAVELED. AN OPEN CUT-DOWN WAS PERFORMED CONTRALATERALLY, AND THE UNRAVELED SHEATH, WHICH WAS HELD TOGETHER BY THE UNRAVELED COIL, WAS PULLED THROUGH THE IPSILATERAL SITE AND COMPLETELY REMOVED FROM THE PATIENT. PER THE REPORTER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE COMPLAINT DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105204 ↗
• MalfunctionMar 31, 2025Break; Break

  AS REPORTED, UPON COMPLETION OF AN ANGIOGRAM, A FLEXOR ANSEL GUIDING SHEATH SEPARATED UPON REMOVAL OF THE DEVICE OVER A WIRE GUIDE. CONTRALATERAL ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY, AND THE DEVICE WAS ADVANCED THROUGH A BYPASS TO TARGET THE POPLITEAL ARTERY. THE ACCESS SITE WAS SCARRED; HOWEVER, THE ANATOMY WAS REPORTEDLY NOT STENOSED, TORTUOUS, OR CALCIFIED, AND THE BIFURCATION WAS NOT STEEP. MULTIPLE WIRE GUIDES WERE USED WITH THE DEVICE, MOSTLY INCLUDING ANOTHER MANUFACTURER¿S 0.018-INCH AND 0.035-INCH WIRES, AS WELL AS OTHER MANUFACTURERS¿ CATHETERS AND BALLOONS. RESISTANCE WAS ENCOUNTERED UPON ADVANCEMENT OF THE SHEATH; HOWEVER, AFTER THE PHYSICIAN DILATED THE TRACT, THE SHEATH ADVANCED ¿FINE¿. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF ANCILLARY DEVICES THROUGH THE SHEATH. THE DILATOR WAS NOT REINSERTED PRIOR TO SHEATH REMOVAL. UPON REMOVAL, THE SHEATH SEPARATED BUT WAS HELD TOGETHER BY ¿THE BRAIDING¿ AND REMAINED ON THE WIRE GUIDE. BECAUSE THE SEPARATED SECTIONS REMAINED ON THE WIRE, THE PHYSICIAN WAS ABLE TO CONTINUE PULLING ON THE SHEATH, REMOVING IT ENTIRELY BY HAND. THE WIRE WAS REMOVED WITH THE SHEATH. A SECTION OF THE DEVICE DID NOT REMAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729545 ↗
• MalfunctionJan 9, 2025Break; Break

  AS REPORTED, DURING AN INTERVENTIONAL ANGIOGRAM OF THE LOWER EXTREMITY, A FLEXOR ANSEL GUIDING SHEATH UNRAVELED AND SEPARATED UPON REMOVAL OF THE DEVICE. RETROGRADE ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY TO TARGET THE MID-TO-DISTAL SUPERFICIAL FEMORAL ARTERY. RESISTANCE WAS ENCOUNTERED UPON BOTH INSERTION AND REMOVAL OF THE DEVICE, AS THE VESSELS WERE HIGHLY CALCIFIED, AND THE SHEATH WAS PUSHED AND PULLED THROUGH A TIGHT ILIAC LESION. AFTER INTRODUCTION AND ADVANCEMENT OF THE SHEATH INTO THE SUPERFICIAL FEMORAL ARTERY, AN UNSPECIFIED GLIDE CATHETER WAS PLACED IN THE SHEATH, OVER AN UNSPECIFIED AMPLATZ WIRE; HOWEVER, THE CATHETER WOULD NOT ADVANCE THROUGH THE SHEATH. AN UNKNOWN ROSEN WIRE WAS ALSO USED DURING THE PROCEDURE. PER THE REPORTER, WHILE REMOVING THE CATHETER AND SHEATH, THE HUB OF THE SHEATH ¿SNAPPED OFF¿, AND A PORTION OF THE SHEATH CAME WITH IT. THE HUB WAS USED TO START PULLING THE SHEATH FROM THE PATIENT. THE CATHETER WAS NOT IN THE SHEATH LUMEN DURING REMOVAL, AND THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE SHEATH OVER THE WIRE GUIDE. THE REMAINING PORTION OF THE SHEATH, WHICH REMAINED IN THE PATIENT, BEGAN TO UNRAVEL AND BREAK OFF. THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113426 ↗
• InjurySep 8, 2022Break; Unraveled Material; Detachment of Device or Device Component; Break; Unraveled Material; Detachment of Device or Device Component

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

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Foreign Body In Patient

  MAUDE report 15383637 ↗
• MalfunctionSep 27, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED, A FLEXOR ANSEL GUIDING SHEATH BECAME TWISTED DURING AN ANGIOPLASTY PROCEDURE. THE COMPLAINT DEVICE WAS INSERTED VIA THE PATIENT'S GROIN IN A CONTRALATERAL APPROACH TO THE AFFECTED SITE. THE ACCESS POINT WAS SCARRED. THE ANATOMY WAS TORTUOUS AND CALCIUM WAS PRESENT. ANOTHER MANUFACTURER'S GLIDE CATHETER WAS INSIDE THE COMPLAINT FLEXOR ANSEL GUIDING SHEATH WHEN IT TWISTED AND BECAME STUCK. IN ORDER TO REMOVE THE GLIDE WIRE FROM THE COMPLAINT DEVICE IT WAS NECESSARY TO REMOVE BOTH THE COMPLAINT DEVICE AND THE WIRE TOGETHER. A BUDDY WIRE WAS INSERTED NEXT TO THE SHEATH AND WHEN THE FLEXOR ANSEL GUIDING SHEATH WAS REMOVED, IT UNRAVELED. ANOTHER SHEATH WAS PLACED OVER THE BUDDY WIRE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 Known Impact Or Consequence To Patient

  MAUDE report 7914785 ↗
• MalfunctionSep 19, 2018Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, THE BRAIDED LINE OF THE FLEXOR ANSEL GUIDING SHEATH UNRAVELED AND SEPARATED UPON REMOVAL. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED REGARDING EVENT DETAILS AND PATIENT OUTCOME. 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 Known Impact Or Consequence To Patient

  MAUDE report 7891207 ↗