Flexor G29981Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00827002299818), received between Aug 30, 2017 and Feb 18, 2026 — classified as 6 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Break; Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOGRAM OF THE LEFT LEG VIA ACCESS IN THE RIGHT GROIN, THE HUB OF A FLEXOR ANSEL GUIDING SHEATH SEPARATED FROM THE SHAFT. THE PATIENT WAS HEPARINIZED DURING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380663 ↗
• MalfunctionMay 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHILE THE USER WAS REMOVING A FLEXOR ANSEL GUIDING SHEATH FROM THE PATIENT DURING AN UNSPECIFIED VASCULAR PROCEDURE, THE CHECK-FLO VALVE ASSEMBLY "SNAPPED OFF". 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 EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054904 ↗
• InjuryApr 5, 2024Break; Break

  AS ORIGINALLY REPORTED, DURING AN UNKNOWN PROCEDURE, THE HUB OF A FLEXOR ANSEL GUIDING SHEATH DISCONNECTED DURING USE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. UPON RETURN OF THE COMPLAINT DEVICE, THE SHAFT OF THE SHEATH WAS SEPARATED BELOW THE HUB, WITH THE FLARE REMAINING IN THE SHEATH HUB.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050207 ↗
• InjuryJan 8, 2024Break; Break

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

  Patient problems: Foreign Body In Patient

  MAUDE report 18469288 ↗
• MalfunctionOct 24, 2023Break; Stretched; Unraveled Material; Break; Stretched; Unraveled Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995092 ↗
• InjuryOct 11, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 01NOV2023. CONTRALATERAL ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY TO TARGET THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS MINIMALLY SCARRED DUE TO PREVIOUS OPERATIONS. THE "HAIRPIN" AORTIC BIFURCATION WAS STEEP BUT NOT CALCIFIED. ANOTHER MANUFACTURER'S WIRE GUIDE AND OTHER MANUFACTURERS' CATHETERS, BALLOONS, AND STENTS WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. NO RESISTANCE WAS FELT UPON INSERTION OF THE COMPLAINT SHEATH; HOWEVER, RESISTANCE WAS FELT DURING REMOVAL OF ANOTHER MANUFACTURER'S BALLOON THROUGH THE SHEATH AND DURING SHEATH EXCHANGE WITH AN UNSPECIFIED SHORT SHEATH. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE SHEATH; HOWEVER, ANOTHER MANUFACTURER'S 0.035-INCH WIRE WAS IN THE SHEATH WHEN THE SEPARATION OCCURRED. THE SEPARATED SHEATH WAS REMOVED FROM THE PATIENT BY SURGICALLY OPENING THE COMMON FEMORAL ARTERY AND WITHDRAWING THE SHEATH.

  Patient problems: Foreign Body In Patient

  MAUDE report 17915052 ↗
• InjurySep 6, 2023Break; Break

  AS REPORTED, AT THE END OF AN ENDOVASCULAR PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH SEPARATED INTO THREE PIECES UPON REMOVAL OF THE DEVICE. TWO OF THE FRAGMENTS WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE CASE WAS CONVERTED TO AN OPEN PROCEDURE IN ORDER TO REMOVE THE THIRD FRAGMENT. THE PATIENT REQUIRED MULTIPLE BLOOD TRANSFUSIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17694613 ↗
• MalfunctionJun 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126549 ↗
• MalfunctionJul 5, 2022Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  AS ORIGINALLY REPORTED, PRIOR TO USE DURING A PROCEDURE TO PLACE A RENAL STENT, THE DILATOR WOULD NOT ENTER A FLEXOR ANSEL GUIDING SHEATH. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND A NEW SHEATH WAS USED TO COMPLETE THE PROCEDURE. 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. UPON INVESTIGATION OF THE DEVICE ON 22JUN2022, SHEATH DELAMINATION WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914343 ↗
• MalfunctionFeb 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A VETERINARY PROCEDURE INVOLVING A CANINE PATIENT, THE HEMOSTATIC VALVE OF A FLEXOR ANSEL GUIDING SHEATH LEAKED THROUGH THE PORT. THE SHEATH WAS INSERTED INTO THE FEMORAL ARTERY FOR APPROXIMATELY "40 MINUTES" AND THE LEAK WAS NOTED UPON REMOVAL OF THE DILATOR. THE CANINE PATIENT LOST A "MODERATE" AMOUNT OF BLOOD DURING THE PROCEDURE. NO BLOOD PRODUCTS OR TRANSFUSIONS WERE NECESSARY DUE TO THE BLOOD LOSS. THE CANINE PATIENT'S OUTCOME OF THE PROCEDURE WAS A "FULL UNEVENTFUL RECOVERY." 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13550968 ↗
• MalfunctionFeb 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN LEG PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH LEAKED "AROUND" THE DEVICE. A HEMATOMA DEVELOPED AT THE PUNCTURE SITE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hematoma

  MAUDE report 13509589 ↗
• MalfunctionNov 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2021. THE EVENT OCCURRED DURING AN ANGIOGRAM. THE HUB SEPARATED AS THE USER REMOVED THE DEVICE FROM THE GROIN BY PULLING ON THE HUB. THE DILATOR AND A WIRE GUIDE WERE IN THE SHEATH LUMEN. THE ANATOMY WAS NOT TORTUOUS, SCARRED, OR CALCIFIED AND RESISTANCE WAS NOT ENCOUNTERED. "A LITTLE" BLOOD LOSS WAS REPORTED; HOWEVER, THERE WAS NO INTERVENTION TAKEN TO TREAT BLOOD LOSS. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12740670 ↗
• MalfunctionJun 2, 2021Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922381 ↗
• MalfunctionAug 14, 2020Material Separation; Unraveled Material; Detachment of Device or Device Component; Material Separation; Unraveled Material; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10407087 ↗
• MalfunctionJan 9, 2020Material Separation; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9569863 ↗
• MalfunctionOct 22, 2019Material Separation; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9219434 ↗
• MalfunctionOct 22, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER ON 22OCT2019. THE DEVICE BECAME STUCK AS IT WAS BEING PULLED BACK. THE DILATOR WAS REINSERTED TO AID IN REMOVAL OF THE DEVICE. THE PROCEDURE WAS COMPLETED IN "NORMAL MANNER", WITHOUT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9217623 ↗
• MalfunctionAug 2, 2019Material Separation; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8855325 ↗
• MalfunctionMay 3, 2019Stretched; Stretched

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE PROCEDURE BEING PERFORMED WAS A LEG ANGIOGRAM. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED AS A RESULT OF THIS SEPARATION. REPORTEDLY, THE SHEATH WAS ONLY IN PLACE FOR LESS THAN FIVE MINUTES, BUT THE PATIENT'S ANATOMY WAS SAID TO HAVE HAD SCARRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579350 ↗
• MalfunctionMar 15, 2019Material Separation; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426173 ↗
• InjuryJul 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, DURING AN ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY, THE HUB DETACHED FROM THE FLEXOR ANSEL GUIDING SHEATH. CONTRALATERAL ACCESS WAS GAINED THROUGH THE COMMON FEMORAL ARTERY IN THE GROIN. THERE WAS NO DIFFICULTY ON INSERTION. AS THE PHYSICIAN WAS INTRODUCING AN ANGIOPLASTY BALLOON THROUGH THE COMPLAINT DEVICE, THE COMPLAINT DEVICE ADVANCED INSIDE THE ARTERY AND THE HUB DETACHED. THE PROCEDURE WAS ABORTED IN ORDER TO PERFORM A SURGICAL CUT-DOWN OF THE ARTERY AND MANUALLY REMOVE THE FLEXOR ANSEL GUIDING SHEATH. NO INFORMATION WAS AVAILABLE REGARDING VESSEL TORTUOSITY OR CALCIFICATION. NO INFORMATION HAS BEEN REPORTED REGARDING COMPLETION OF THE ANGIOPLASTY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7678323 ↗
• InjuryAug 30, 2017Detachment Of Device Component; Detachment Of Device Component

  A FLEXOR ANSEL GUIDING SHEATH WAS USED IN A LOWER EXTREMITY ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS REPORTED THAT, ANOTHER MANUFACTURERS BALLOON WAS RE-INSERTED INTO THE LEFT LEG OF THE PATIENT FOR ADDITIONAL PROLONGED LOW-PRESSURE ANGIOPLASTY. THERE WAS SOME RESISTANCE RE-INSERTING THE BALLOON; HOWEVER, WHEN MODERATE FORCE WAS USED THE BALLOON ADVANCED. AS THE BALLOON WAS ADVANCING THE HUB DETACHED FROM THE SHAFT OF THE SHEATH AND REMAINED IN THE PATIENT. THE HUB WAS REMOVED AND A 9 FRENCH SHEATH AND A SNARE WERE SLID OVER THE WIRE. THE 9 FRENCH SHEATH AND FRACTURED FLEXOR SHEATH WERE REMOVED AS A UNIT. THE 9 FRENCH SHEATH WAS RE-INSERTED TO FINISH THE CASE. TWO NON-COOK VASCULAR CLOSURE DEVICES WERE USED TO CLOSE THE INSERTION SITE; HOWEVER, THEY DID NOT WORK ON THE 9 FRENCH HOLE AND PRESSURE HAD TO BE HELD FOR 30 MINUTES. NO ADDITIONAL ADVERSE EVENTS OCCURRED.

  Patient problems: No Code Available

  MAUDE report 6830300 ↗