Flexor G29985Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002299856), received between Oct 15, 2014 and May 14, 2025 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOGRAM OF THE LEG, THE HUB OF A FLEXOR ANSEL GUIDING SHEATH SEPARATED UPON REMOVAL OF ANOTHER MANUFACTURER¿S ATHERECTOMY CATHETER FROM THE DEVICE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019090 ↗
• MalfunctionSep 12, 2024Peeled/Delaminated; Peeled/Delaminated

  AS ORIGINALLY REPORTED, DURING AN UNSPECIFIED PROCEDURE, ANOTHER MANUFACTURER'S STENT WAS DIFFICULT TO INSERT INTO TWO FLEXOR ANSEL GUIDING SHEATHS. PER THE REPORTER, THE STENT WAS MEANT FOR USE WITH A 7-FRENCH SHEATH, AND THE DILATORS WERE EASILY ADVANCED INTO THE SHEATHS. CONTRALATERAL ACCESS WAS OBTAINED IN THE RIGHT SIDE TO TARGET THE LEFT COMMON ILIAC ARTERY. THE ANATOMY WAS STENOSED. THE USER ENCOUNTERED A "GREAT DEAL" OF RESISTANCE WHEN ATTEMPTING TO INSERT THE STENT THROUGH THE FIRST SHEATH; THEREFORE, THE STENT WAS REMOVED, AND THE SHEATH WAS EXCHANGED FOR A NEW DEVICE FROM THE SAME LOT; HOWEVER, THE USER WAS NOT ABLE TO ADVANCE THE STENT ALL THE WAY THROUGH THE SECOND SHEATH. PER THE REPORTER, THE SECOND SHEATH AND THE STENT SYSTEM BECAME "BONDED TOGETHER" AND WERE RETURNED TO THE MANUFACTURER OF THE STENT. UNKNOWN WIRE GUIDES AND UNSPECIFIED COOK CATHETERS WERE ALSO USED THROUGH THE SHEATHS DURING THE PROCEDURE. AN UNSPECIFIED 8-FRENCH SHEATH AND A NEW STENT WERE USED TO COMPLETE THE PROCEDURE. NOTHING REMAINED IN THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE HOSPITALIZATION OR ADDITIONAL PROCEDURES DUE TO THIS EVENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. ONE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20202763 ↗
• MalfunctionAug 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING TREATMENT OF OCCLUSIVE PERIPHERAL ARTERY DISEASE IN THE RIGHT LEG, THE HUB OF A FLEXOR ANSEL GUIDING SHEATH SEPARATED FROM THE DEVICE. A COOK BALLOON AND ANOTHER MANUFACTURER'S WIRE WERE USED DURING THE PROCEDURE. ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TARGET THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED, THE AORTIC BIFURCATION WAS NOT STEEP OR CALCIFIED, AND THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE SHEATH, OR DURING INSERTION OR REMOVAL OF OTHER DEVICES THROUGH THE SHEATH. AFTER USING THE BALLOON, IT WAS COMPLETELY DEFLATED AND THE USER ATTEMPTED TO REMOVE THE BALLOON THROUGH THE SHEATH; HOWEVER, THE HUB OF THE SHEATH SEPARATED, RESULTING IN BLOOD LEAKAGE FROM THE SHEATH. THE PHYSICIAN STOPPED THE BLOOD LEAK, USING HIS HAND, AND SUBSEQUENTLY REMOVED AND EXCHANGED THE SHEATH. THE NEW SHEATH WAS USED TO CONTINUE THE PROCEDURE, INVOLVING TREATMENT OF A LESION BELOW-THE-KNEE. PER THE USER, "NOT TOO MUCH" BLOOD WAS LOST; THEREFORE, THE PATIENT DID NOT REQUIRE ANY TREATMENT FOR BLOOD LOSS. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470840 ↗
• MalfunctionMay 16, 2023Detachment of Device or Device Component; 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: Insufficient Information

  MAUDE report 16941334 ↗
• MalfunctionSep 15, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING PREPARATION FOR AN UNKNOWN PROCEDURE, THE TIP OF A FLEXOR ANSEL GUIDING SHEATH WAS NOTED TO BE SPLIT. THIS WAS OBSERVED PRIOR TO PATIENT CONTACT. THE DEVICE WAS NOT USED, AND ANOTHER 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432685 ↗
• MalfunctionAug 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE TARGETING THE LEFT RENAL ARTERY, A FLEXOR ANSEL GUIDING SHEATH LEAKED AT THE HUB UPON INSERTION OF THE DEVICE INTO THE RIGHT COMMON FEMORAL ARTERY. THE ANATOMY WAS REPORTEDLY NORMAL, AND RESISTANCE WAS NOT ENCOUNTERED FOLLOWING THE INITIAL PUNCTURE. AFTER THE DILATOR WAS REMOVED FROM THE SHEATH, THE HUB BEGAN TO SPRAY TINY STREAMS OF BLOOD AROUND THE WIRE GUIDE. THE SHEATH WAS REMOVED, AND ANOTHER DEVICE OF THE SAME PRODUCT REFERENCE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. 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 15269458 ↗
• MalfunctionJul 8, 2021Crack; Crack

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140162 ↗
• MalfunctionJun 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN UP AND OVER AORTIC BIFURCATION PROCEDURE AND USING A FLEXOR ANSEL GUIDING SHEATH, TWO CHECK FLOW VALVES DISCONNECTED DURING THE CATHETER EXCHANGE. THE PHYSICIAN HAD THE SHEATH IN PLACE. WHEN HE ATTEMPTED TO DO THE CATHETER EXCHANGE, THE VALVE DISCONNECTED FROM THE SHEATH. THE SHEATH WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER SHEATH FROM THE SAME LOT NUMBER. IT ADVANCED INTO THE PATIENT NORMALLY, BUT ONCE AGAIN THE CHECK FLO VALVE DISCONNECTED WHEN THE ATTEMPTED TO DO THE CATHETER EXCHANGE. THEY REMOVED THIS SHEATH AS WELL. THE PROCEDURE WAS COMPLETED BY USING A TERUMO SHEATH. NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT WAS REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086091 ↗
• MalfunctionMar 4, 2021Fluid/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 11417862 ↗
• MalfunctionDec 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

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

  MAUDE report 11035999 ↗
• MalfunctionSep 10, 2020Material Separation; Material Separation

  THE ANATOMY WAS NOT TORTUOUS OR CALCIFIED. THE DILATOR WAS NOT IN PLACE WHEN THE SEPARATION OCCURRED AND THE SHEATH AND DILATOR WERE NOT REMOVED AS A UNIT. THE HUB AND SHEATH WERE HELD AS THE DEVICE WAS REMOVED FROM THE PATIENT. RESISTANCE WAS NOT REPORTED ON INSERTION OR REMOVAL OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515624 ↗
• MalfunctionNov 18, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

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

  Patient problems: No Patient Involvement

  MAUDE report 9334672 ↗
• MalfunctionOct 10, 2017Material Deformation; Material Deformation

  A FLEXOR ANSEL GUIDING SHEATH WAS USED IN A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT REVISION PROCEDURE. IT WAS REPORTED THAT THE VESSEL WAS DILATED UP TO A 10F, AND WHEN THEY WERE PLACING THE SHEATH OVER A J-WIRE IT "CRINKLED/BUNCHED". ANOTHER SHEATH WAS OPENED AND THE PROCEDURE WAS 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 6937579 ↗
• MalfunctionJun 13, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE PREPPING FOR A PERIPHERAL ANGIOGRAM PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH WAS REMOVED FROM THE PACKAGING AND IT WAS NOTED THAT IT HAD A TIGHT DILATOR TIP AND WOULD NOT GO OVER THE WIRE. DURING PRELIMINARY INVESTIGATION IT WAS ASCERTAINED THAT THIS SHEATH HAD MINOR PINCH-TYPE DAMAGE ¿ SPLITTING ON THE TIP AND A HANGNAIL (1820334-2017-01235). THIS WAS PUT ASIDE AND A SECOND FLEXOR ANSEL GUIDING SHEATH WAS OPENED. THIS DEVICE WAS NOTED TO HAVE A LIP BETWEEN THE SHEATH AND DILATOR TRANSIT. THE SECOND DEVICE WAS PUT ASIDE AND NOT USED. IT WAS EVENTUALLY ASCERTAINED THAT THE SECOND SHEATH HAD MODERATE DAMAGE CONSISTING OF SHARP EDGES AND SPLITTING ON THE TIP (1820334-2017-01236). A THIRD DEVICE FROM THE SAME LOT WAS OPENED AND USED FOR THE PROCEDURE, WHICH WORKED WELL. 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. NEITHER DEVICE WAS USED ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6639020 ↗
• MalfunctionJun 13, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHILE PREPPING FOR A PERIPHERAL ANGIOGRAM PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH WAS REMOVED FROM THE PACKAGING AND IT WAS NOTED THAT IT HAD A TIGHT DILATOR TIP AND WOULD NOT GO OVER THE WIRE. DURING INVESTIGATION IT WAS ASCERTAINED THAT THIS SHEATH HAD MINOR PINCH-TYPE DAMAGE ¿ SPLITTING ON THE TIP AND A HANGNAIL (1820334-2017-01235). THIS WAS PUT ASIDE AND A SECOND FLEXOR ANSEL GUIDING SHEATH WAS OPENED. THIS DEVICE WAS NOTED TO HAVE A LIP BETWEEN THE SHEATH AND DILATOR TRANSIT. THE SECOND DEVICE WAS PUT ASIDE AND NOT USED. IT WAS EVENTUALLY ASCERTAINED THAT THE SECOND SHEATH HAD MODERATE DAMAGE CONSISTING OF SHARP EDGES AND SPLITTING ON THE TIP (1820334-2017-01236). A THIRD DEVICE FROM THE SAME LOT WAS OPENED AND USED FOR THE PROCEDURE, WHICH WORKED WELL. 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. NEITHER DEVICE WAS USED ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6639000 ↗
• MalfunctionMay 12, 2017Break

  IT WAS OBSERVED THAT THE PLASTIC CONNECTOR HAD BROKEN THROUGH THE PACKAGING. THIS PRODUCT PROBLEM COMPROMISED THE STERILITY OF THE DEVICE, BUT IT WAS NOTED PRIOR TO ANY PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6562765 ↗
• MalfunctionJan 31, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE THE SHEATH WAS INSERTED AND THE DOCTOR WAS MANIPULATING THE WIRE, THE HUB/CHECK FLO VALVE SNAPPED OFF. THE SHEATH WAS REMOVED AND ANOTHER SHEATH WAS INSERTED. THE PATIENT REMAINED UNHARMED. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6290961 ↗
• InjuryOct 15, 2014Material Separation; Unraveled Material

  THE FACILITY WAS HAVING PREVIOUS DIFFICULTIES GETTING ACCESS WITH A TERUMO SHEATH AND NOW THEY HAVE DECIDED TO USE COOK FLEXOR.

  Patient problems: Foreign body, removal of

  MAUDE report 4188083 ↗