Flexor G29983Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00827002299832), received between Apr 1, 2016 and Apr 9, 2026 — classified as 5 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Detachment of Device or Device Component

  AS REPORTED, DURING AN ANGIOGRAM, THE SIDE-ARM SEPARATED FROM A FLEXOR ANSEL GUIDING SHEATH¿S HUB. A STIFFENED MICROPUNCTURE DEVICE WAS USED TO OBTAIN ACCESS IN THE FEMORAL ARTERY TO TARGET THE SUPERFICIAL FEMORAL, POPLITEAL, AND POSTERIOR TIBIAL ARTERIES. THE VESSELS WERE DESCRIBED AS ¿THREADY OR RATTY¿ AND CALCIFIED. ANOTHER MANUFACTURER¿S GUIDE WIRE AND CATHETER WERE USED DURING THE PROCEDURE, AS WELL AS A COOK CATHETER AND WIRE. THE DILATOR WAS NOT IN PLACE AT THE TIME OF THE EVENT. BECAUSE THE PROCEDURE WAS ALMOST OVER, THE USER RECONNECTED THE SIDE-ARM AND HELD IT IN PLACE TO INJECT CONTRAST. 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 REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24828900 ↗
• MalfunctionJul 16, 2024Detachment 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751596 ↗
• MalfunctionSep 28, 2023Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING A FEMORAL ANGIOPLASTY, A FLEXOR ANSEL GUIDING SHEATH SEPARATED. THE SHEATH "PINCHED" ANOTHER MANUFACTURER'S WIRE GUIDE AND WAS UNABLE TO BE REMOVED. THE INTRODUCER "LOST ITS COATING" AND BROKE IN TWO. NO PART OF THE SHEATH REMAINS IN THE PATIENT. 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 17837533 ↗
• MalfunctionJun 22, 2023Stretched; Stretched

  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 17183228 ↗
• MalfunctionMay 31, 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 17032736 ↗
• InjuryJul 14, 2022Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  AS REPORTED, DURING AN UNSPECIFIED VASCULAR CASE, A FLEXOR ANSEL GUIDING SHEATH SEPARATED AT THE HUB AND SUBSEQUENTLY UNRAVELED UPON REMOVAL OF THE DEVICE. ACCESS WAS OBTAINED IN THE GROIN. THE ANATOMY WAS CALCIFIED, AND "SOME" RESISTANCE WAS ENCOUNTERED UPON INSERTION AND/OR REMOVAL OF THE DEVICE. THE DILATOR WAS NOT REINSERTED PRIOR TO REMOVAL OF THE DEVICE, AND NOTHING WAS IN THE SHEATH LUMEN AT THE TIME OF SEPARATION. THE HUB WAS NOT USED TO PULL THE DEVICE FROM THE PATIENT. A CUT-DOWN WAS PERFORMED AT THE END OF THE PROCEDURE TO REMOVE THE SEPARATED PORTION OF THE SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15016058 ↗
• MalfunctionJul 6, 2020Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, A FLEXOR ANSEL GUIDING SHEATH'S OUTER PACKAGE WAS NOT SEALED. THE COMPONENTS FELL OUT OF THE OUTER PACKAGE AS THE DEVICE WAS HUNG FOR STORAGE. THE INDIVIDUAL COMPONENTS INSIDE THE PACKAGE SEEMED "FINE". THE DEVICE WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 10232838 ↗
• MalfunctionJul 6, 2020Unsealed Device Packaging; Unsealed Device Packaging

  ADDITIONAL INFORMATION WAS RECEIVED. THE BOTTOM OUTER PACKAGE WAS NOT SEALED. REPORTEDLY, THE CONTENT INSIDE WAS "FINE", SO THE DEVICE WAS USED.

  Patient problems: No Patient Involvement

  MAUDE report 10232805 ↗
• MalfunctionDec 18, 2019Unsealed Device Packaging; Unsealed Device Packaging

  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 9488759 ↗
• MalfunctionSep 13, 2019Detachment 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: No Known Impact Or Consequence To Patient

  MAUDE report 9022791 ↗
• MalfunctionJul 23, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  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 8816550 ↗
• MalfunctionJul 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN ARTERIAL LYSIS PROCEDURE INVOLVING A MALE PATIENT OF UNKNOWN AGE, THE HUB/VALVE OF A FLEXOR ANSEL GUIDING SHEATH SEPARATED FROM THE SHEATH IN THE MIDDLE OF THE PROCEDURE DURING SLIGHT MANIPULATION TO MINIMALLY RETRACT THE DEVICE. THE PATIENT, DESCRIBED AS "HUSKY", HAD A HISTORY OF A PREVIOUS SURGICAL CUT-DOWN IN THE SAME AREA (FEMORAL) WITH SCAR TISSUE AND CALCIFICATION PRESENT FROM PREVIOUS INTERVENTION. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY FOR A LOWER LEG INTERVENTION. THE COMPLAINT DEVICE WAS IN PLACE FOR LESS THAN ONE HOUR. RESISTANCE WAS REPORTED DURING THE PROCEDURE. ANOTHER MANUFACTURER'S EKOS CATHETER WAS IN THE LUMEN OF THE DEVICE AT THE TIME OF THE EVENT; HOWEVER, THE DILATOR WAS IN THE LUMEN OF THE DEVICE. THE HUB WAS USED TO PULL THE DEVICE DURING MANIPULATION, AT THE TIME OF HUB SEPARATION. AN ANGIOGRAM WAS ALSO PERFORMED DURING THE PROCEDURE. BLOOD LOSS WAS REPORTED TO BE LESS THAN 10 MILLILITERS. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE OUTCOME WAS REPORTEDLY "AS EXPECTED". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777137 ↗
• InjuryJun 25, 2019Material Separation; Material Separation

  AS REPORTED, DURING A BILATERAL LOWER EXTREMITY ANGIOGRAM, A FLEXOR ANSEL GUIDING SHEATH SEPARATED INSIDE THE PATIENT. THE (B)(6) YEAR-OLD FEMALE PATIENT, WEIGHING (B)(6) POUNDS, REPORTEDLY HAD A HISTORY OF PERIPHERAL ARTERY DISEASE, HYPERTENSION, DIABETES MELLITUS, STAGE IV CHRONIC KIDNEY DISEASE, ATRIAL FIBRILLATION, AND CONGESTIVE HEART FAILURE. AN UNKNOWN MANUFACTURER'S 5 FRENCH BALLOON WAS UTILIZED THROUGH THE SHEATH, AS WELL AS AN UNKNOWN 0.035 INCH WIRE GUIDE. THE SEPARATION OCCURRED AS THE DEVICE WAS BEING REMOVED, WITH THE UNKNOWN 0.035 INCH WIRE GUIDE IN THE LUMEN OF THE DEVICE AT THE TIME OF REMOVAL. THE PATIENT'S ANATOMY WAS NOT REPORTED TO BE TORTUOUS OR CALCIFIED. ADDITIONAL WIRES, ANOTHER MANUFACTURER'S CATHETER, AND ANOTHER MANUFACTURER'S SNARE WERE USED TO RETRIEVE THE RETAINED SHEATH. 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 Code Available

  MAUDE report 8732137 ↗
• MalfunctionJul 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, DURING AN ARTERIOGRAM VIA CONTRALATERAL GROIN ACCESS, THE HUB OF THE FLEXOR ANSEL GUIDING SHEATH DETACHED WHILE BEING REMOVED. ACCORDING TO THE COMPLAINANT THE WIRE GUIDE WAS IN PLACE DURING DEVICE REMOVAL. ANOTHER FLEXOR ANSEL GUIDING SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE COMPLAINANT DENIED THE PATIENT'S ANATOMY WAS TORTUOUS OR CALCIFIED; HOWEVER, THE PATIENT DID HAVE MULTIPLE PREVIOUS ACCESS SITES IN THE GROIN. 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 7678397 ↗
• MalfunctionMar 21, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ABDOMEN WITH RUNOFF PROCEDURE, THE FLEXOR ANSEL GUIDING SHEATH HUB BROKE OFF UPON REMOVAL. THERE WERE NO DEVICES BEING UTILIZED THROUGH THE SHEATH AT THE TIME OF THE SEPARATION. THE SHEATH WAS PLACED IN THE PATIENT'S LEG VIA A CONTRALATERAL APPROACH. A WIRE GUIDE (MANUFACTURER UNSPECIFIED) WAS INSERTED INTO THE LUMEN OF THE SHEATH PRIOR TO REMOVAL. 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 7358339 ↗
• MalfunctionJul 24, 2017Material Separation; Material Separation

  IT WAS REPORTED DURING A PERIPHERAL ANGIOGRAPHY PROCEDURE USING A FLEXOR ANSEL GUIDING SHEATH, THE HUB OF THE SHEATH CAME OFF WHEN THEY WERE TRYING TO REPOSITION. THE DEVICE WAS TAKEN OFF OVER THE WIRE AND A NEW DEVICE WAS OPENED AND PLACED OVER THE WIRE. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH THE NEW DEVICE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6736733 ↗
• MalfunctionJul 21, 2017Material Frayed; Device Damaged Prior to Use; Material Frayed; Device Damaged Prior to Use

  IT WAS REPORTED THAT, PRIOR TO PATIENT CONTACT, WHILE BEING PREPPED ON THE BACK TABLE, IT WAS NOTED THE END OF THE SHEATH WAS ALLEGEDLY FRAYED/SPLIT. AS A RESULT, ANOTHER DEVICE WAS USED FOR THE PROCEDURE. NO ADVERSE EVENTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6732446 ↗
• MalfunctionMay 18, 2017Split

  THE REPORTED INFORMATION INDICATED THAT THE SHEATH'S TIP WAS SPLIT OPEN BEFORE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AS A RESULT OF THE EVENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY AND NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6575599 ↗
• MalfunctionMay 16, 2017Split

  DURING AN UNKNOWN PROCEDURE, THE PHYSICIAN USED A MICROPUNCTURE SET AND THEN ATTEMPTED TO ACCESS THE PUNCTURE SITE WITH THE SHEATH. HOWEVER, THE TIP OF THE SHEATH SPLIT. 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 6571079 ↗
• MalfunctionMay 16, 2017Break

  PRIOR TO PATIENT CONTACT, THE CUSTOMER FOUND THAT THE SHEATH WAS BROKEN AT THE PROXIMAL END. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PARTS OF THE DEVICE REMAINED INSIDE THE PATIENT AND NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6569494 ↗
• MalfunctionMay 16, 2017Split

  THE CUSTOMER FOUND THAT THE SHEATH WAS SPLIT AT THE PROXIMAL END, PRIOR TO INSERTION INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PARTS OF THE DEVICE REMAINED INSIDE THE PATIENT. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6569304 ↗
• MalfunctionMay 16, 2017Material Protrusion/Extrusion

  IT WAS REPORTED THE TIP OF THE SHEATH WHERE THE SHEATH IS SUPPOSED TO STOP, THE DARKER PORTION OF IT IS STICKING OUT AND SEEMS TO BE CUT AT AN ANGLE WHICH INSPECTION REVEALED IS THE TRT TUBING USED IN THE CURVING PROCESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6568502 ↗
• MalfunctionMay 12, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LOWER EXTREMITY ANGIOGRAM PROCEDURE, USING A FLEXOR ANSEL GUIDING SHEATH, WHILE ATTEMPTING TO RETRACT THE SHEATH THE HEMOSTATIC VALVE CAME APART FROM THE SHEATH AND THE SHEATH BEGAN TO UNCOIL. IT WAS REPORTED THAT THE END USER WAS ABLE TO REMOVE THE DEVICE AND FINISH THE PROCEDURE. THERE WAS NO UNINTENDED SECTION OF THE DEVICE THAT REMAINED INSIDE THE PATIENT'S BODY. THERE NO ADVERSE EFFECTS ON THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6565022 ↗
• MalfunctionMay 12, 2017Split

  DURING AN ENDOVASCULAR PROCEDURE THE PHYSICIAN USED A MICROPUNCTURE SET TO ATTEMPT TO ACCESS THE PUNCTURE SITE WITH THE SHEATH. HOWEVER, THE TIP OF THE SHEATH SPLIT. 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 6564793 ↗
• MalfunctionMay 12, 2017Material Integrity Problem

  THE PHYSICIAN DISCOVERED THAT THE SHEATH WAS DAMAGED WHEN HE INSERTED IT. THE DEVICE WAS REPLACED WITH A NEW ONE. IMAGES OF THE DEVICE DEPICTED JAGGED EDGES AT THE TIP OF THE SHEATH. THE PATIENT DID NOT EXPERIENCE ANY REPORTED ADVERSE EFFECTS RELATED TO THE OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6564408 ↗