FOGARTY 12TLW405F35Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00690103043488), received between Jan 17, 2020 and Apr 19, 2026 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K240078, K892410); they may or may not involve this specific model.

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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2026Material Fragmentation

  AS REPORTED, THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER WAS RUPTURED (SEE PICTURE ATTACHED). THERE IS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER PRODUCT EVALUATION FINDINGS, BALLOON WAS FOUND TO BE RUPTURED LONGITUDINALLY. BALLOON EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED REGION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921271 ↗
• MalfunctionMar 18, 2026Deflation Problem

  AS REPORTED DURING USE THE FOGARTY CATHETER BALLOON DID NOT DEFLATE. THE CLINICIAN TRIED TO DEFLATE THE BALLOON MULTIPLE TIMES USING THE SYRINGE THAT COMES WITH THE DEVICE AND ADDITIONAL SYRINGES ON THE FIELD BUT THE ISSUE WAS NOT RESOLVED. EVENTUALLY, THEY HAD TO PULL THE DEVICE BACK INTO THE SHEATH AS FAR AS THEY COULD WHICH CAUSED THE BALLOON TO POP. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631378 ↗
• MalfunctionMar 18, 2026Deflation Problem

  AS REPORTED DURING USE THE FOGARTY CATHETER BALLOON DID NOT DEFLATE. THE CLINICIAN TRIED TO DEFLATE THE BALLOON MULTIPLE TIMES USING THE SYRINGE THAT COMES WITH THE DEVICE AND ADDITIONAL SYRINGES ON THE FIELD BUT THE ISSUE WAS NOT RESOLVED. EVENTUALLY, THEY HAD TO PULL THE DEVICE BACK INTO THE SHEATH AS FAR AS THEY COULD WHICH CAUSED THE BALLOON TO POP. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631158 ↗
• MalfunctionDec 29, 2025Burst Container or Vessel; Material Fragmentation; Burst Container or Vessel; Material Fragmentation

  AS REPORTED, DURING TESTING PRIOR INSERTION OF THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON BURST WHEN TRYING TO INFLATE IT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS RECEIVED, THE BALLOON WAS FOUND TO BE RUPTURED IN THE CENTRAL AREA. BALLOON EDGES DID NOT MATCH AT THE RUPTURED REGION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906882 ↗
• MalfunctionSep 3, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT, BEFORE INSERTION, THE BALLOON OF A FOGARTY CATHETER COULD NOT DEFLATE. A SECOND CATHETER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS NOTED THAT THE DEVICE WAS NOT CHECKED BEFORE STARTING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22959689 ↗
• MalfunctionAug 18, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED DURING USE THE FOGARTY EMBOLECTOMY CATHETER BALLOON BURST IN AN EMBOLIZATION CASE. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828419 ↗
• MalfunctionJun 19, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, WHEN TESTING THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON LEAKED SALINE. AS PER PRODUCT EVALUATION FINDINGS, THE BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA. BOTH BALLOON WINDINGS WERE INTACT. THE EDGES OF LATEX DID NOT APPEAR TO MATCH UP. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292217 ↗
• MalfunctionFeb 11, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING USE IN PATIENT, IN THIS FOGARTY EMBOLECTOMY CATHETER THE BALLOON BURST. THE ISSUE WAS SOLVED REPLACING THE UNIT. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE EDGES OF THE RUPTURED BALLOON DID NOT MATCH. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353010 ↗
• MalfunctionJan 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE, A KINK OCCURRED IN THIS FOGARTY CATHETER ON THE SIDE WHERE THE SYRINGE IS CONNECTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231354 ↗
• MalfunctionJan 13, 2025Contamination; Contamination

  AS REPORTED, DURING TESTING THIS FOGARTY EMBOLECTOMY CATHETER, IT WAS FOUND SOMETHING STICKY INSIDE. THEREFORE, THE DEVICE WAS NOT USED IN PATIENT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138558 ↗
• MalfunctionAug 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE WITH A 12TLW405F35 FOGARTY CATHETER, THE BALLOON SHEERED OFF AND WAS LEFT INSIDE THE PATIENT. UNKNOWINGLY, IT WAS FOUND A WEEK LATER DURING A DE-CLOT PROCEDURE (DATE NOT PROVIDED). THIS REQUIRED ANOTHER PROCEDURE AND THE FOREIGN BODY WAS REMOVED FROM THE PATIENT. THE ORIGINAL INTENDED PROCEDURE WAS A LEFT FOREARM LOOP GRAFT DE-CLOT. THIS EVENT TOOK PLACE IN THE MONTH OF APRIL. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Foreign Body In Patient

  MAUDE report 20081389 ↗
• InjuryMar 20, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH A FOGARTY THRU LUMEN EMBOLECTOMY CATHETER, DURING USE. THE FACILITY STATES THE CATHETER SPLIT IN THE PATIENT. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOR REMOVAL. DURING THROMBECTOMY, WHILE USING THE CATHETER OVER THE WIRE PLACED IN THE ARTERIAL DIRECTION, THE FOGARTY BALLOON WAS PASSED OVER THE ARTERIAL ANASTOMOSIS, INFLATED, AND PULLED BACK INTO THE PATIENTS GRAFT. AFTER A COUPLE PASSES THE DOCTOR REALIZED THE BALLOON WAS NOT INFLATING UNDER FLUORO AND PULLED THE CATHETER OUT OF THE SHEATH TO INSPECT THE BALLOON. WHILE REMOVING THE CATHETER HE REALIZED THE CATHETER HAD SPLIT IN HALF AND UNDER FLUORO YOU COULD VISIBLY SEE THE REMAINDER OF THE CATHETER INSIDE THE PATIENTS GRAFT. RETRIEVAL FORCEP WAS USED WITHOUT SUCCESS. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR SURGERY FOR RETRIEVAL OF THE REMAINING CATHETER. THE PIECE OF THE DEVICE THAT WAS SURGICALLY REMOVED IS NOT AVAILABLE FOR RETURN. LOCATION AND TYPE OF GRAFT, LEFT UPPER ARM GRAFT. PERCENTAGE OF GRAFT OCCLUDED, 100 PERCENT. PER THE CUSTOMER, IT IS THE PRACTICE OF THIS FACILITY TO USE THE FOGARTY THRU LUMEN CATHETER VERSUS THE GRAFT THROMBECTOMY CATHETER TO PERFORM A THR

  Patient problems: Foreign Body Embolism

  MAUDE report 18946494 ↗
• MalfunctionMar 20, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH A FOGARTY THRU LUMEN EMBOLECTOMY CATHETER, DURING USE. PER THE CUSTOMER, THE TECHNICIAN THAT WAS IN THE CASE DID NOT PREP THE DEVICE BEFORE STARTING THE CASE. THE ISSUE COULD HAVE BEEN FOUND BEFORE USE. THE DOCTOR WAS ABLE TO INFLATE THE CATHETER BALLOON, BUT COULD NOT DEFLATE ENOUGH TO PULL IT OUT OF THE SHEATH. THE SHEATH AND THE CATHETER WERE REMOVED AND A NEW SHEATH WAS INSERTED WITH A NEW CATHETER. THERE WAS NO PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942810 ↗
• MalfunctionMar 20, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH THE FOGARTY THRU LUMEN EMBOLECTOMY CATHETER, DURING USE. THE BALLOON STOPPED INFLATING AND DEFLATING. THERE WAS NO MEDICAL INTERVENTION. THE BALLOON WAS REMOVED SUCCESSFULLY, HOWEVER, THERE WAS DIFFICULTY WITH DEFLATION. ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, BUT THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942738 ↗
• MalfunctionMar 15, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON OF A FOGARTY CATHETER HAD DEFLATION DIFFICULTIES. PER FOLLOW UP WITH REP, NO INFORMATION WAS AVAILABLE ON WHETHER THE BALLOON WAS EVENTUALLY ABLE TO BE DEFLATED. NO ADDITIONAL INCISION WAS REQUIRED TO REMOVE THE CATHETER. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913143 ↗
• MalfunctionDec 20, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A FOGARTY CATHETER HAD INFLATION AND DEFLATION DIFFICULTIES. EVENT OCCURRED DURING PREP AND BEFORE PROCEDURE. CATHETER WAS EXCHANGED WITH A SECOND CATHETER. NO PATIENT INVOLVEMENT. PER FOLLOW UP WITH CUSTOMER, THE BALLOON WAS ABLE TO DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370149 ↗
• MalfunctionJun 29, 2023Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  IT WAS REPORTED THAT A 12TLW405F35 FOGARTY CATHETER FAILED DURING A DE-CLOT PROCEDURE, LEAVING A SMALL PIECE OF THE CATHETER TIP BROKEN OFF WITH THE BALLOON FRAGMENT IN THE ARTERIAL ANASTOMOSIS BRACHIAL ARTERY OF THE PATIENT. THE DOCTOR ATTEMPTED TO RETRIEVE THE PIECES FOR APPROXIMATELY 30 MINUTES, BUT UNSUCCESSFUL. THE PATIENT WAS BROUGHT TO THE OR SHORTLY AFTER AND RETRIEVAL OF ALL PARTS OF THE CATHETER WERE SUCCESSFUL. THE SCRUB TECH CONFIRMED TESTING THE BALLOON WITH AIR AND THEN PLACING IT IN A SMALL BOWL OF SALINE TO CHECK FOR LEAKAGE AND FOUND NO ISSUES WITH THE DEVICE PRIOR TO INSERTION IN THE PATIENT. THE DOCTOR CONFIRMED NO HARM TO THE PATIENT. THE CATHETER IS AVAILABLE FOR RETURN ONCE ALL THE PIECES HAVE BEEN RECEIVED FROM PATHOLOGY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17232904 ↗
• MalfunctionJun 29, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A 12TLW405F35 FOGARTY CATHETER BALLOON COULD NOT DEFLATE DURING A PROCEDURE. THE CUSTOMER MADE SURE THAT THE CATHETER WAS NOT IN THE LOCKED POSITION AND THE BALLOON WOULD STILL NOT DEFLATE. THE CATHETER WAS REMOVED FROM THE PATIENT BY ATTACHING A BIGGER SYRINGE AND NEGATIVE PRESSURE WAS DRAWN ON THE BALLOON TO DEFLATE IT ENOUGH TO GET IT OUT THROUGH THE SHEATH. THEY CONFIRMED NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17232211 ↗
• MalfunctionApr 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE BALLOON ON A FOGARTY CATHETER SEPARATED FROM THE CATHETER WHILE STILL IN THE PATIENT. NO SNARE WAS USED TO REMOVE THE SEPARATED BALLOON. INSTEAD, THE DOCTOR USED ANOTHER FOGARTY WITH A BIGGER INTRODUCER TO PIN DEVICE AND REMOVE BALLOON. NO ADDITIONAL TROUBLESHOOTING STEPS WERE ATTEMPTED, NO OTHER EDWARDS PRODUCTS WERE INVOLVED, AND NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16683056 ↗
• MalfunctionJan 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING USE, A FOGARTY CATHETER MODEL 12TLW405F35, LOT 64405987, WAS NOTED TO BE LEAKING THROUGH THE LUMEN UPON INFLATION. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16179544 ↗
• MalfunctionAug 31, 2022Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  IT WAS REPORTED VIA MEDWATCH REPORT 0500690000 2022 8005 THAT DURING A THROMBECTOMY OF AN AV FISTULA IN IR, A MODEL 12TLW405F35, LOT 64354693, BROKE WHILE BEING PULLED BACK ACROSS THE ARTERIAL ANASTOMOSIS. A PORTION OF THE CATHETER AND THE INFLATED BALLOON REMAINED IN THE PATIENT, AND BOTH REQUIRED EXTRACTION. THERE WAS NO ALLEGATION OF PATIENT COMPLICATIONS.

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

  MAUDE report 15329899 ↗
• MalfunctionDec 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT, BEFORE USE, THIS CATHETER LEAKED AND RUPTURED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908788 ↗
• MalfunctionNov 9, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT WHILE THE PHYSICIAN HAD DIFFICULTY INFLATING AND DEFLATING THIS CATHETER BEFORE USE. DEFLATION TOOK A MINUTE TO DEFLATE. IT WAS NOT USED ON PATIENT YET, THE CLINICIAN WAS TESTING THE DEVICE. THE SYRINGE IS STILL ATTACHED TO THE CATHETER. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783396 ↗
• MalfunctionNov 7, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A FOGARTY WAS OPENED AND THE BALLOON DID NOT INFLATE AND DEFLATE PROPERLY. THE BALLOON WOULD EVENTUALLY DEFLATE BUT TOOK MORE THAN A MINUTE. IT WAS TESTED BEFORE PROCEDURE STARTED SO THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756109 ↗
• InjuryJan 17, 2020Material Rupture

  DURING EMBOLIZATION PROCEDURE FOR AN AV FISTULA, BALLOON ON CATHETER RUPTURED. WHEN CATHETER WAS REMOVED FROM VASCULAR SITE, BALLOON WAS NO LONGER ATTACHED. FDA SAFETY REPORT ID: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9610903 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K240078, K892410. One submission often covers many models, so check the product and lot details in each record.

• Z-0238-2024 · Sep 7, 2023 · Open, Classified
  Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35