FOGARTY 120403FRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00690103043242), received between Apr 17, 2023 and Sep 15, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, WHEN TESTING THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER, IT BURST. THERE IS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER PRODUCT EVALUATION FINDINGS, BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA. BALLOON EDGES APPEARED TO MATCH AT THE RUPTURED REGION. SPRING TIP WIRE WAS VISIBLE. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051914 ↗
• MalfunctionSep 8, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, WHEN TESTING THIS FOGARTY ARTERIAL EMBOLECTOMY CATHETER, BALLOON DID NOT INFLATE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER EVALUATION RESULTS, BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA. BALLOON EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED REGION. SPRING TIP WIRE WAS VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990062 ↗
• MalfunctionSep 4, 2025Material Separation; Physical Resistance/Sticking

  ON ATTEMPTING TO PASS THE EMBOLECTOMY CATHETER DISTALLY IN THE ULNAR WE WERE MET WITH SIGNIFICANT RESISTANCE PULLING BACK AND ACTUALLY SEPARATED THE TIP OF THE EMBOLECTOMY CATHETER. HAD TO CUT DOWN THE ULNAR ARTERY TO RETRIEVE THE TIPS OF THE CATHETERS.

  Patient problems: Insufficient Information

  MAUDE report 22962746 ↗
• MalfunctionAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED DURING USE THE BALLOON TIP OF A FOGARTY CATHETER WAS LEFT IN THE BOVINE GRAFT DURING DECLOT OF THE LEFT UPPER ARM. IT BROKE OFF INTO THE GRAFT AND THEY WERE UNABLE TO FIND IT. THE SURGEON STATED THAT THE PATIENT WAS GOING TO INTERVENTIONAL RADIOLOGY FOR REMOVAL. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22738633 ↗
• InjuryJun 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AFTER HEPARIN ADMINISTRATION, CLAMPING TRANSVERSELY THE INFLOW AND OUTFLOW WITH A NUMBER 11 BLADE AND, BEING USED PROXIMALLY UNTIL HAVING CLEAN PASS OF THE ULNAR ARTERY, THIS 3F FOGARTY CATHETER TIP DETACHED. THE BACK BLEEDING WAS QUITE SUBSTANTIAL; THEN, PAPAVERINE AND WARM SALINE WERE APPLIED, BEING ABLE TO RETRIEVE THE FOGARTY CATHETER. SINCE IT WAS UNSURE IF THE DETACHED TIP REMAINED INSIDE THE PATIENT, ANOTHER 3F FOGARTY CATHETER WAS INSERTED ALL THE WAY TO THE WRIST BUT NO OBSTRUCTION WAS FOUND. THE ARTERIOTOMY WAS CLOSED USING 6-0 PROLENE SUTURES IN RUNNING FASHION FROM EACH APEX. AND THE SUTURE LINE WAS CHECKED FOR HEMOSTASIS. NEEDLE HOLE BLEEDING WAS CONTROLLED WITH THE TOPICAL APPLICATION OF SURGICEL. FLOW WAS RE-ESTABLISHED AND CONFIRMED TO BE EXCELLENT BY CW DOPPLER EVALUATION, THAT REVEALED TRIPHASIC FLOW SIGNALS TO ALL BRANCHES CONFIRMING THAT THE DISTAL TIP WAS NOT IN THE PATIENT. QUANTITY OF BLOOD LOSS WAS UNKNOWN. PATIENT WAS DISCHARGED HOME WITH NO COMPLICATIONS A FEW DAYS AFTER THE SURGERY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22192354 ↗
• MalfunctionMay 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED DURING USE THE TIP BALLOON OF A FOGARTY CATHETER MAY HAVE FALLEN OFF INSIDE THE BRACHIAL RADIAL ARTERY. THE CATHETER BALLOON PORTION WAS NOTED TO BE DISASSEMBLED UPON REMOVAL. PER THE PHYSICIAN IT WAS LEFT IN THE PATIENTS LEFT FOREARM. THERE WAS NO PATIENT INJURY. THE DEVICE WILL NOT BE AVAILABLE FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22115233 ↗
• MalfunctionNov 11, 2024Inadequacy of Device Shape and/or Size; Material Twisted/Bent; Inadequacy of Device Shape and/or Size; Material Twisted/Bent

  IT WAS REPORTED THAT THE BALLOON OF THIS FOGARTY CATHETER INFLATED ECCENTRICALLY DURING USE. THE BALLOON INFLATION WAS CHECKED BEFORE USE AND NO PROBLEM WAS FOUND. HOWEVER, AFTER INSERTING THE CATHETER INTO THE PATIENT, THE CATHETER TIP BENT AND THE BALLOON DID NOT INFLATE SYMMETRICALLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20657959 ↗
• MalfunctionMay 9, 2023Material Separation; Material Separation

  IT WAS REPORTED VIA MEDWATCH 4900240000 2023 8061 THAT THE BALLOON SEPARATED FROM THE CATHETER AFTER USE. CATHETER WAS INSPECTED BY DOCTOR AND NOTED THAT THE BALLOON WAS INTACT PRIOR TO USE. AFTER USE, THE BALLOON WAS NO LONGER ATTACHED AND WAS UNABLE TO BE LOCATED ON THE STERILE FIELD. FORGARTY WAS PASSED PROXIMAL IN THE SUPERIOR MESENTERIC ARTERY. ON THE LAST PROXIMAL PASS, THE BALLOON APPEARED TO HAVE BROKE AND COULD NOT BE FOUND. PER FOLLOW UP WITH CUSTOMER, THERE WERE NO FURTHER ATTEMPTS MADE TO RETRIEVE OR LOCATE MISSING BALLOON, NO TROUBLESHOOTING ATTEMPTS MADE, NO ADDITIONAL PRODUCTS USED, AND NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899300 ↗
• MalfunctionApr 17, 2023Detachment of Device or Device Component

  DOCTOR ASKED FOR SHORT 3F FOGARTY BALLOON. IT WAS GIVEN TO STERILE SCRUB AND WAS INSPECTED BY DOCTOR AND INTACT. AFTER USE IT WAS APPARENT THAT THE BALLOON END OF THE CATHETER WAS NO LONGER ATTACHED AND WAS UNABLE TO BE LOCATED ON THE STERILE FIELD. FOGARTY WAS PASSED PROXIMAL IN THE SUPERIOR MESENTERIC ARTERY. OF NOTE, ON THE LAST PROXIMAL PASS OF THE FOGARTY THE BALLOON APPEARS TO HAVE BROKEN AND COULD NOT BE FOUND

  Patient problems: Foreign Body In Patient

  MAUDE report 16750948 ↗