Flexor G29989Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002299894), received between May 16, 2017 and Jul 6, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE INVOLVING INTERVENTION OF THE RIGHT LEG VIA CONTRALATERAL ACCESS IN THE LEFT GROIN, THE HUB OF A FLEXOR ANSEL GUIDING SHEATH SEPARATED. PER THE REPORTER, AS THE SHEATH WAS REMOVED FROM THE LEFT GROIN, OVER A WIRE GUIDE AND ¿UP AND OVER¿, THE CHECK-FLO VALVE CAME OFF. THE DILATOR AND GUIDEWIRE WERE IN THE LUMEN OF THE SHEATH WHEN THE SEPARATION OCCURRED. THE SHEATH HUB WAS USED TO PULL THE DEVICE FROM THE PATIENT. THE ACCESS SITE WAS "NORMAL", THE ANATOMY WAS NOT STENOSED, CALCIFIED, OR TORTUOUS. THE BIFURCATION WAS ACUTE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR ADVANCEMENT OF THE SHEATH OR DURING INSERTION OR ADVANCEMENT OF ANY DEVICE THROUGH THE SHEATH. RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE SHEATH. ANOTHER MANUFACTURER'S LASER AND BALLOON WERE USED THROUGH THE SHEATH DURING THE PROCEDURE. 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 25722288 ↗
• MalfunctionJun 19, 2026Contamination /Decontamination Problem

  AS REPORTED, FOREIGN MATTER RESEMBLING A HAIR WAS NOTED IN A FLEXOR ANSEL GUIDING SHEATH¿S PACKAGE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563430 ↗
• MalfunctionSep 12, 2024Unraveled Material; 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 20206732 ↗
• MalfunctionJun 6, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073686 ↗
• MalfunctionDec 1, 2022Peeled/Delaminated; Peeled/Delaminated

  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 15895987 ↗
• MalfunctionNov 14, 2019Fluid/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 Consequences Or Impact To Patient

  MAUDE report 9323170 ↗
• InjuryOct 1, 2019Material Separation; Unraveled Material; Material Separation; Unraveled Material

  AS REPORTED, DURING AN AORTO-ILIAC-FEMORAL (AIF) ARTERIOGRAM WITH INTERVENTION, INVOLVING A (B)(6) FEMALE PATIENT, A FLEXOR ANSEL GUIDING SHEATH UNRAVELED PRIOR TO THE INTERVENTION. THE PATIENT REPORTEDLY HAD A HISTORY OF CORONARY ARTERY DISEASE, PERIPHERAL ARTERY DISEASE, DIABETES, A PREVIOUS UNSPECIFIED BYPASS, APPENDECTOMY, AND CHOLECYSTECTOMY. ACCESS WAS OBTAINED IN THE RIGHT RADIAL ARTERY AND THE DEVICE WAS TO BE ADVANCED INTO THE AORTA TO "GET AS CLOSE TO THE ILIAC AS POSSIBLE". THE PATIENT WAS GIVEN A LOADING DOSE AND AN ADDITIONAL DOSE OF HEPARIN PRIOR TO INTRODUCTION OF THE SHEATH; AND DILAUDID, MAGNESIUM, AND PHENYLEPHRINE WERE GIVEN DURING THE PROCEDURE. OTHER MANUFACTURER'S WIRE GUIDES WERE USED DURING THE PROCEDURE. THE DEVICE WAS NOT ABLE TO BE ADVANCED AND THE DILATOR WAS REINSERTED FOR A REPEATED ATTEMPT AT ADVANCEMENT. THE PHYSICIAN MET RESISTANCE WHEN REMOVING THE DILATOR AND THE SHEATH UNRAVELED. THERE WERE NO REPORTS OF VESSEL TORTUOSITY, CALCIFICATION, OR SCARRING. THE SHEATH WAS REPORTEDLY IN PLACE FOR APPROXIMATELY 15 MINUTES. THE WIRE AND SHEATH WERE LEFT IN THE PATIENT'S ARM AND AN ARTERIOGRAM WAS PERFORMED, CONFIRMING UNRAVELING OF THE DEVICE APPROXIMATELY

  Patient problems: No Code Available

  MAUDE report 9139497 ↗
• MalfunctionSep 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, UPON REMOVAL OF A FLEXOR ANSEL GUIDING SHEATH AT THE COMPLETION OF AN UNSPECIFIED PROCEDURE FOR PERIPHERAL ARTERY DISEASE, THE HUB SEPARATED FROM THE SHEATH. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND THE TARGET LOCATION WAS BELOW THE KNEE. ANOTHER MANUFACTURER'S BALLOON AND ATHERECTOMY DEVICE WERE USED DURING THE PROCEDURE, AS WELL AS A COOK AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE. THE PATIENT DID NOT HAVE CALCIFIED, TORTUOUS, OR SCARRED ANATOMY. THE SHEATH WAS ABLE TO BE REMOVED BY HAND AND NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT'S OUTCOME WAS REPORTED AS "GOOD". 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 9010145 ↗
• MalfunctionAug 10, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION RECEIVED 15AUG2019: REPORTEDLY, A MONTH OR TWO PRIOR TO THE REPORTED EVENT, THE PATIENT EXPERIENCED CRAMPING AND NUMBNESS OF THE LEFT LEG UPON WALKING; FOLLOWED BY SEVERE PAIN IN THE LEFT GREAT TOE. A CT ANGIOGRAPHY SCAN REVEALED SOFT TISSUE EDEMA OF THE LEFT GREAT TOE AND OCCLUSION OF THE ANTERIOR TIBIAL ARTERY. THE ANTERIOR TIBIAL PULSE WAS NOT PALPABLE AT THAT TIME; ALTHOUGH, THE POSTERIOR TIBIAL PULSE WAS REPORTEDLY "GOOD". THE PATIENT UNDERWENT A PERIPHERAL ARTERY ANGIOGRAPHY WITH ANGIOPLASTY ON (B)(6) 2019 WITH GOOD RESULTS. DURING THE PROCEDURE, ANOTHER MANUFACTURER'S 0.14 CATHETER WAS ADVANCED TO THE LEFT ANTERIOR TIBIAL ARTERY OVER ANOTHER MANUFACTURER'S GUIDE WIRE. THE WIRE WAS REMOVED FOR RESHAPING ANDS THEN RE-ADVANCED THROUGH THE CATHETER ACROSS THE LEFT ANTERIOR TIBIAL LESION. THE CATHETER WAS REMOVED AND ANOTHER MANUFACTURER'S BALLOON WAS ADVANCED INTO THE LESION. THE BALLOON WAS THEN PULLED BACK AND THE GUIDE WIRE WAS REMOVED. AN ANGIOGRAM WAS PERFORMED ON THE LOWER LEFT LEG AND THE BALLOON WAS REMOVED. REPORTEDLY, THE COMPLAINT DEVICE "BROKE OFF" AS THE PHYSICIAN WAS REMOVING THE SHEATH. A GUIDE WIRE WAS INSERTED INTO THE DISTAL PORTION OF TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8881664 ↗
• MalfunctionMay 10, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT THE END OF A SUBCLAVIAN STENTING PROCEDURE, THE PHYSICIAN NOTED THERE WAS A LEAK OF THE TUBING AT THE SIDE OF THE FLEXOR ANSEL GUIDING SHEATH; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (TPA) BALLOON AND STENTS WERE BEING UTILIZED THROUGH THE COMPLAINT DEVICE AT THE TIME. REPORTEDLY THE SHEATH WAS WORKING FINE AND THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE COMPLAINT DEVICE. 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 7503092 ↗
• InjuryFeb 27, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTERIOGRAM, THE FLEXOR ANSEL GUIDING SHEATH CAME APART INSIDE OF THE PATIENT'S ANATOMY UPON INSERTION. ALL PORTIONS OF THE SHEATH WERE ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT HARM. ACCESS WAS GAINED THROUGH THE PATIENT'S LEG VIA CONTRALATERAL APPROACH. A 0.035 INCH DIAMETER BENTSON WIRE GUIDE (MANUFACTURER UNSPECIFIED) WAS BEING UTILIZED THROUGH THE SHEATH DURING THE EVENT. 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 Code Available

  MAUDE report 7299679 ↗
• MalfunctionAug 8, 2017Material Separation; Material Separation

  A FLEXOR ANSEL GUIDING SHEATH WAS USED FOR A STENT PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE END USER HAD THE SHEATH IN THE PATIENT AND PLACED A ZILVER PTX STENT. THE PHYSICIAN THEN WENT IN WITH A BALLOON TO POST DILATE THE STENT. HE PULLED THE CHECK FLO VALVE OFF OF THE SHEATH IN ERROR AS HE THOUGHT HE WAS PULLING OUT THE BALLOON. THE WIRE WAS IN AND HE PLACED A NEW SHEATH TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY AND NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6774193 ↗
• MalfunctionMay 16, 2017Material Separation

  IT WAS REPORTED THAT WHILE THE DEVICE WAS BEING PREPPED, THE OUTER SHAFT SEPARATED FROM THE INNER SHAFT AT THE PROXIMAL HUB. THIS EVENT OCCURRED PRIOR TO PATIENT CONTACT. 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 6568516 ↗