Flexor G29996Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002299962), received between Apr 14, 2016 and Mar 14, 2024 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2024Peeled/Delaminated; Difficult to Remove; Unraveled Material; Peeled/Delaminated; Difficult to Remove; Unraveled Material

  AS REPORTED, UPON COMPLETION OF AN ANGIOGRAM OF THE LEFT LEG, A FLEXOR ANSEL GUIDING SHEATH "SHEERED". ACCESS WAS OBTAINED IN THE RIGHT GROIN TO TARGET THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE BIFURCATION WAS "PRETTY ACUTE" AND CALCIFIED, HOWEVER, THERE WAS NO RESISTANCE ADVANCING THE SHEATH OR ANY DEVICE, INCLUDING ANOTHER MANUFACTURER'S BALLOONS, THROUGH THE SHEATH. UPON REMOVAL OF THE SHEATH AFTER THE PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED, RESISTANCE WAS FELT AND THE DILATOR WAS INSERTED. RESISTANCE WAS STILL FELT, HOWEVER, THE SHEATH WAS SUCCESSFULLY REMOVED AND "SHEERING" WAS NOTED APPROXIMATELY MIDWAY DOWN THE SHEATH. PER THE REPORTER, THE SHEATH LOOKED LIKE IT HAD BEEN "TRAVELED OVER ROUGH TERRAIN AND WAS VERY RATTY". THERE WAS NO SEPARATION OF THE SHEATH. 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 OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, A HOLE WAS NOTED IN THE SHEATH EXPOSING THE INNER COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18906518 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA A CASE STUDY, PRESENTED DURING AN ENDOVASCULAR SYMPOSIUM, A FLEXOR ANSEL GUIDING SHEATH WAS USED DURING A PROCEDURE INVOLVING EMBOLIZATION OF THE INTERNAL ILIAC ARTERY, PRIOR TO ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF THE BILATERAL COMMON ILIAC ARTERIES. A CONTRALATERAL APPROACH WAS USED FOR EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY, USING A 6-FRENCH COOK FLEXOR ANSEL GUIDING SHEATH. THE PATIENT COMPLAINED OF BACK PAIN AND BEGAN YAWNING. THE PATIENT'S BLOOD PRESSURE DECREASED, AND THE HEART RATE DROPPED TO LESS THAN THIRTY BEATS PER MINUTE. THE USER SUSPECTED THAT THE PATIENT'S LOWER BACK PAIN STIMULATED THE VAGUS NERVE, CAUSING BRADYCARDIA. ATROPINE WAS ADMINISTERED VIA RAPID INFUSION, AND AN INTRAVENOUS DOPAMINE DRIP WAS STARTED. THE PATIENT'S CONDITION GRADUALLY IMPROVED, AND THE PATIENT WAS TREATED WITH A 14-MILLIMETER VASCULAR PLUG. THREE DAYS LATER, A CONTRAST-ENHANCED CT SCAN NOTED A RETROGRADE TYPE A AORTIC DISSECTION (RTAD). THE USER REPORTED THAT THE DISSECTION MAY HAVE OCCURRED DURING EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY DUE TO INSERTION IF THE SHEATH VIA A CONTRALATERAL APPROACH. THE ACUTE STAGE HAD PASSED, AND THE FALSE LUMEN WITHIN THE

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 17757432 ↗
• MalfunctionNov 15, 2021Material Frayed; Material Frayed

  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 12815905 ↗
• MalfunctionOct 23, 2018Fracture; Fracture

  PRIOR TO AN UNKNOWN PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH WAS NOTED TO HAVE A "CRACK" IN THE TIP OF THE DEVICE. ANOTHER SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THIS DEVICE WAS OBSERVED TO BE CRACKED UPON OPENING THE PACKAGE. IT DID NOT MAKE PATIENT CONTACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED. THE CUSTOMER HAS STATED THE DEVICE WILL NOT BE RETURNED. PICTURES OF THE DEVICE HAVE BEEN REQUESTED; HOWEVER, NONE ARE AVAILABLE AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 7995733 ↗
• InjuryJun 25, 2018Material Separation; Material Separation

  IT WAS REPORTED, DURING A LEFT HEART CATHETERIZATION VIA THE RADIAL ARTERY, THE FLEXOR ANSEL GUIDING SHEATH BROKE JUST PAST THE HUB DURING REMOVAL. REPORTEDLY, THE ARTERY WAS IN SPASM. SUBSEQUENTLY, MEDICATIONS WERE GIVEN TO DECREASE THE ARTERIAL SPASM AND A BALLOON WAS INFLATED IN ORDER TO REMOVE THE COMPLAINT DEVICE. ACCORDING TO THE COMPLAINANT, THE SHEATH WAS COMPLETELY REMOVED WITHOUT ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 7634386 ↗
• MalfunctionDec 28, 2017Material Frayed; Failure to Advance; Material Frayed; Failure to Advance

  IT WAS REPORTED THAT DURING TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO) LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA), THE DILATOR WAS INSERTED AND THE FLEXOR ANSEL GUIDING SHEATH WAS ATTEMPTED TO BE ADVANCED USING A CONTRALATERAL APPROACH FROM THE FEMORAL ARTERY TO THE CTO. A CALCIFIED LESION WAS NOTED TO BE PRESENT AT THE FEMORAL ARTERY (ACCESS SITE), AND THE SHEATH WAS UNABLE TO ENTER THE ARTERY AS THE TIP HAD A BLUNT EDGE. AS A RESULT, THE SHEATH TIP BECAME FRAYED, AND ANOTHER MANUFACTURER'S DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. 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 7151481 ↗
• MalfunctionAug 9, 2017Material Frayed; Material Frayed

  A FLEXOR ANSEL GUIDING SHEATH WAS USED IN THE TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA ). THE PROCEDURE WAS PERFORMED BY CONTRALATERAL APPROACH FROM THE GROIN. THERE WERE CALCIFICATIONS NOTED IN THE PUNCTURE SITE (GROIN). AFTER A 4FR. SHORT SHEATH, DETAILS UNKNOWN, WAS INSERTED INTO THE ARTERY, THE PHYSICIAN ATTEMPTED TO ADVANCE THE COMPLAINT DEVICE INTO THE PATIENT'S BODY OVER A WIRE GUIDE. IT WOULD NOT ENTER THE ARTERY AND AS A RESULT, THE TIP BECAME DEFORMED, RESULTING IN FRAYING. ANOTHER MANUFACTURER'S SHEATH WAS USED INSTEAD, WITHOUT PROBLEM. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED DO TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6776476 ↗
• MalfunctionJul 20, 2017Material Frayed; Difficult to Insert; Material Frayed; Difficult to Insert

  IT WAS REPORTED AFTER INSERTION OF THE 4FR SHORT SHEATH, THE PHYSICIAN ATTEMPTED TO INSERT THE DEVICE INTO THE PATIENT (CONTRALATERAL APPROACH). HOWEVER, IT COULD NOT BE INSERTED INTO THE VESSEL RESULTING IN DAMAGE (FRAY) IN THE DILATOR TIP. AS A RESULT, THE SHEATH WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6729794 ↗
• MalfunctionJul 20, 2017Material Frayed; Difficult to Insert; Material Frayed; Difficult to Insert

  IT WAS REPORTED THAT A FLEXOR ANSEL GUIDING SHEATH WAS USED TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). CONTRALATERAL APPROACH WAS GAINED FROM THE GROIN. AFTER INSERTION OF A 4FR. SHORT SHEATH, THE PHYSICIAN ATTEMPTED TO INSERT THE DEVICE INTO THE PATIENT. IT COULD NOT BE INSERTED INTO THE VESSEL RESULTING IN DAMAGE (FRAY) TO THE DILATOR TIP. AS A RESULT, IT WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6728854 ↗
• MalfunctionJun 26, 2017Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) USING A FLEXOR ANSEL GUIDING SHEATH, A CONTRALATERAL APPROACH WAS GAINED FROM THE GROIN. AFTER INSERTION OF A 4FR. SHORT SHEATH, THE PHYSICIAN ATTEMPTED TO INSERT THE DEVICE INTO THE PATIENT. IT COULD NOT BE INSERTED INTO THE VESSEL RESULTING IN DAMAGE (FRAY) IN THE DILATOR TIP. IT WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE AND THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6667213 ↗
• MalfunctionJun 23, 2017Material Frayed; Material Frayed

  IT WAS REPORTED DURING TREATMENT OF A SUPERFICIAL FEMORAL ARTERY (SFA) USING A FLEXOR ANSEL GUIDING SHEATH, CONTRALATERAL APPROACH WAS GAINED FROM THE GROIN TO TREAT THE SFA. AFTER INSERTION OF A 4FR. SHORT SHEATH, THE PHYSICIAN ATTEMPTED TO INSERT THE DEVICE INTO THE PATIENT. IT WAS REPORTED THAT IT COULD NOT BE INSERTED INTO THE VESSEL RESULTING IN DAMAGE (FRAY) IN THE DEVICE TIP. THEN, IT WAS REPLACED WITH A COMPETITOR'S DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6662629 ↗
• MalfunctionJun 9, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, ACCESS WAS GAINED FROM THE FEMORAL ARTERY TO THE LESION OF ILIAC ARTERY, SUPERFICIAL FEMORAL ARTERY AND BELOW THE KNEE CONTRALATERALLY. AFTER PLACEMENT OF A COMPETITOR¿S WIRE GUIDE AND SHORT SHEATH (4FR), AN ATTEMPT WAS MADE TO ADVANCE THE FLEXOR ANSEL GUIDING SHEATH. HOWEVER, IT WOULD NOT ADVANCE INTO THE PATIENT'S BODY BECAUSE IT WAS REPORTEDLY DULL. THERE WAS ALSO A GAP BETWEEN THE DILATOR AND THE SHEATH. A COMPETITOR¿S DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. FURTHER INFORMATION WAS ASCERTAINED THAT THERE WAS DISTAL HANGNAIL DAMAGE AT THE TIP OF THE SHEATH. THERE WAS NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6630033 ↗
• MalfunctionMay 17, 2017Failure to Advance

  IT WAS REPORTED THE DEVICE WAS USED TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) BY CONTRALATERAL APPROACH. ANOTHER MANUFACTURER'S WIRE GUIDE "RADIFOCUS" WAS INSERTED INTO THE PUNCTURE SITE. WHEN THE USER ATTEMPTED TO ADVANCE THE FLEXOR ANSEL GUIDING SHEATH OVER THE WIRE GUIDE, THE WIRE GUIDE WOULD NOT BE INSERTED INTO THE DILATOR TIP. THEREFORE, THE USER CHANGED THE ORIENTATION OF THE FLEXOR AT 180 DEGREES AND ADVANCED IT FROM THE PROXIMAL END (HUB SIDE) OVER THE WIRE GUIDE. THEN, THE WIRE GUIDE COULD PASS THROUGH THE ENTIRE LENGTH OF THE DILATOR, SO THE USER CHANGED THE ORIENTATION OF THE FLEXOR BACK AGAIN AND ADVANCED THE DILATOR FROM THE TIP OVER THE WIRE GUIDE SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH THE FLEXOR SHEATH. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE PHYSICIAN REPORTED THAT THE DILATOR TIP WAS CHECKED CAREFULLY PRIOR TO USE, BUT NO ISSUE WAS VISUALLY FOUND. ALSO, NO FOREIGN MATTER EXITED FROM THE DILATOR WHICH COULD HAVE BLOCKED THE INNER LUMEN. PER FURTHER REVIEW, IT WAS NOTED THAT THE HYDROPHILIC COATING WAS SCRATCH/ FLAKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6572776 ↗
• MalfunctionMay 16, 2017Failure to Advance

  IT WAS REPORTED THAT THE TIP OF THE DILATOR WAS BURRED AND BECAME IMPOSSIBLE TO ADVANCE FURTHER DURING TREATMENT OF SUPERFICIAL FEMORAL ARTERY (SFA) WITH A CONTRALATERAL APPROACH FROM GROIN IN A PATIENT WITH CALCIFIED VESSELS. IT WAS REPLACED WITH ANOTHER ANSEL SHEATH AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. THERE WERE NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6571138 ↗
• MalfunctionMay 16, 2017Device Operates Differently Than Expected

  IT WAS REPORTED UPON INSPECTING THE DEVICE PRIOR TO USE, IT WAS NOTED THERE WAS A BURR AT THE TIP OF THE INTRODUCER. ANOTHER DEVICE WAS USED FOR THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6568625 ↗
• MalfunctionMay 15, 2017Failure to Advance

  IT WAS REPORTED THE PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICES TO SUPERFICIAL FEMORAL ARTERY (SFA) BY CONTRALATERAL AORTIC CROSSOVER APPROACH. ALTHOUGH THE PHYSICIAN TRIED TO CROSS THE AORTIC BIFURCATION WITH THE COMBINATION OF THE FLEXOR ANSEL GUIDING SHEATH AND ANOTHER MANUFACTURER'S WIRE GUIDE. THE FLEXOR ANSEL GUIDING SHEATH WOULD NOT ADVANCE SMOOTHLY, SINCE THE COMPATIBILITY BETWEEN THE DILATOR (THE ONE FOR 0.035INCH) AND WIRE GUIDE WAS "SO BAD." ANOTHER MANUFACTURER'S SHEATH WAS USED WITHOUT PROBLEMS. IT WAS REPORTED THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE DIFFICULTIES. ADDITIONALLY, DEVICE IMAGING IDENTIFIED THE TIP OF THE DILATOR APPEARS TO HAVE DAMAGE CONSISTENT WITH BREAKAGE AND/ OR PEELING OF THE HYDROPHILIC COATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567144 ↗
• MalfunctionApr 20, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKED FROM THE TUOHY-BORST ADAPTER OF THE FLEXOR ANSEL GUIDING SHEATH. IT WAS REPLACED WITH ANOTHER UNSPECIFIED DEVICE WHICH WAS USED WITHOUT PROBLEMS. ALTHOUGH THE SCREW OF THE TUOHY-BORST ADAPTER WAS TIGHTENED, THE VALVE WOULD NOT LOCK COMPLETELY. THUS BLOOD LEAKED FROM THE INNER LUMEN. ACCORDING TO THE PHYSICIAN, THE AMOUNT OF THE BLOOD LEAKED DUE TO THIS EVENT IS UNKNOWN. THE PATIENT RECOVERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6507130 ↗
• InjuryDec 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A VASCULAR SURGEON WAS PERFORMING A PROCEDURE ON THE SUBCLAVIAN. THE SHEATH WAS BEING INTRODUCED WHEN THE PATIENT BEGAN TO HAVE A ANAPHYLACTIC EPISODE, WHICH INCLUDED RESPIRATORY DISTRESS AND THE PATIENT BECAME A DEEP RED COLOR. THE PHYSICIAN ABORTED THE PROCEDURE AT THIS TIME. ¿THE PATIENT WAS STABILIZED AND FINE AND ABLE TO LEAVE THE HOSPITAL.¿ REPORTEDLY ¿THE SAME TYPE OF EPISODE OCCURRED WITH THE PATIENT A COUPLE MONTHS AGO.¿ THE MANUFACTURER HAS REQUESTED ADDITIONAL INFORMATION ABOUT THIS EVENT, AS OF THE DATE OF THIS REPORT A RESPONSE HAS NOT BEEN RECEIVED. THE PATIENT WAS SENT TO WORK WITH AN ALLERGIST IN (B)(6), THE ALLERGIST IS WORKING WITH THE MANUFACTURERS PRODUCT MANAGER TO DETERMINE THE MAKE AND MATERIALS USED TO MANUFACTURER THIS PRODUCT AS IT MAY HAVE CONTRIBUTED TO THE PATIENT'S ALLERGIC REACTION. 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: Hypersensitivity/Allergic reaction; Respiratory Distress

  MAUDE report 6186161 ↗
• InjuryApr 14, 2016Fluid/Blood Leak; Fluid/Blood Leak

  BLOOD LEAKAGE FROM THE TUOHY-BORST WAS CONFIRMED DURING USE. THEN, ANOTHER DEVICE WAS USED INSTEAD TO FINISH THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5575973 ↗