FOGARTY 120804FRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00690103043303), received between Feb 14, 2019 and Aug 20, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2024Failure to Deflate; Failure to Deflate

  AS REPORTED, WHEN INSERTING THIS FOGARTY EMBOLECTOMY CATHETER DURING AN ENDOVASCULAR SURGERY, AFTER INFLATING THE BALLOON, THE BALLOON SLIPPED TO THE TIP OF THE CATHETER AND COULD NOT BE DEFLATED. THERE WAS A DISSECTION OF AN ARTERY AND THE INTERVENTION WAS PROLONGED. NO FURTHER INFORMATION PROVIDED. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 20007062 ↗
• MalfunctionAug 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS IN THE OR FOR A RIGHT AXILLARY BILATERAL FEMORAL THROMBECTOMY WITH ANGIOGRAM. A 4FR FOGARTY CATHETER WAS USED DURING ANGIOGRAM. THE PROVIDER PLACED THE FOGARTY CATHETER IN PATIENTS RIGHT LEG AND INFLATED THE BALLOON AS INDICATED ON THE PACKAGING AND CONFIRMED WITH X-RAY. WHEN THE CATHETER WAS REMOVED IT WAS DISCOVERED THAT THE BALLOON WAS NOT INTACT ON THE CATHETER AND HAD BEEN DISPLACED INSIDE OF THE PATIENT. PROVIDER STATED THAT THE FIRST BALLOON GOT HUNG UP ON WHAT SHE BELIEVES TO BE THE CHRONIC OCCLUDED PLAQUE. SHE HAD TO PULL HARD AND THE BALLOON BROKE AWAY FROM THE CATHETER AND WAS LEFT BEHIND. SHE THEN USED A SECOND BALLOON TO RETRIEVE THE FIRST AND THE EXACT SAME THING HAPPENED SO SHE DID NOT TRY AGAIN. TWO BALLOONS WERE LEFT BEHIND IN THE PATIENT. PROVIDER ALSO STATED THAT IN HER OPINION THE BALLOONS ARE NOT CAUSING ANY OCCLUSION BECAUSE THE VESSEL WAS ALREADY OCCLUDED. THERE WAS NO ALLEGATION OF PATIENT INJURY. DURING SET UP, THE INFLATION TEST WAS COMPLETED WITHOUT ISSUE. THE TWO BALLOONS ARE STILL INSIDE THE PATIENT. THIS COMPLAINT CAPTURES THE SECOND FOGARTY CATHETER USED IN THIS CASE. DEVICE WAS DISCARDED AFTER USE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19986719 ↗
• MalfunctionAug 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS IN THE OR FOR A RIGHT AXILLARY BILATERAL FEMORAL THROMBECTOMY WITH ANGIOGRAM. A 4FR FOGARTY CATHETER WAS USED DURING ANGIOGRAM. THE PROVIDER PLACED THE FOGARTY CATHETER IN PATIENTS RIGHT LEG AND INFLATED THE BALLOON AS INDICATED ON THE PACKAGING AND CONFIRMED WITH X-RAY. WHEN THE CATHETER WAS REMOVED IT WAS DISCOVERED THAT THE BALLOON WAS NOT INTACT ON THE CATHETER AND HAD BEEN DISPLACED INSIDE OF THE PATIENT. PROVIDER STATED THAT THE FIRST BALLOON GOT HUNG UP ON WHAT SHE BELIEVES TO BE THE CHRONIC OCCLUDED PLAQUE. SHE HAD TO PULL HARD AND THE BALLOON BROKE AWAY FROM THE CATHETER AND WAS LEFT BEHIND. SHE THEN USED A SECOND BALLOON TO RETRIEVE THE FIRST AND THE EXACT SAME THING HAPPENED SO SHE DID NOT TRY AGAIN. TWO BALLOONS WERE LEFT BEHIND IN THE PATIENT. PROVIDER ALSO STATED THAT IN HER OPINION THE BALLOONS ARE NOT CAUSING ANY OCCLUSION BECAUSE THE VESSEL WAS ALREADY OCCLUDED. THERE WAS NO ALLEGATION OF PATIENT INJURY. DURING SET UP, THE INFLATION TEST WAS COMPLETED WITHOUT ISSUE. THE TWO BALLOONS ARE STILL INSIDE THE PATIENT. THIS COMPLAINT CAPTURES THE FIRST FOGARTY CATHETER USED IN THIS CASE. DEVICE WAS DISCARDED AFTER USE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19986064 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHEN BRINGING THIS FOGARTY CATHETER OUT FROM PATIENT, WHICH WAS USED FOR A BLOCKED FEMORAL ARTERY, THE BALLOON DETACHED FROM THE CATHETER, LEAVING IT INSIDE THE PATIENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19803813 ↗
• MalfunctionJun 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN AXILLARY BIFEMORAL BYPASS PROCEDURE THE BALLOON BECAME DETACHED FROM A FOGARTY 4FR MODEL 120804F CATHETER AND WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW FOGARTY CATHETER. PER THE CUSTOMER, IT WAS DETERMINED THAT NO ADDITIONAL PROCEDURE WAS PERFORMED BASED ON RISK TO THE PATIENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19635784 ↗
• MalfunctionJun 12, 2020Break

  FROM STAFF: WHILE USING A FOGARTY EMBOLECTOMY CATHETER THE TIP BROKE OFF IN THE PATIENT. THE TIP WAS RETRIEVED BY THE SURGEON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10147895 ↗
• InjuryFeb 14, 2019Break; Detachment of Device or Device Component

  THE BALLOON ON THE FOGARTY CATHETER BROKE AND REMAINED INSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8343631 ↗