Fogarty 120602FPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103205206), received between Dec 1, 2021 and Jun 29, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 6, 2022Open, Classified

   Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

   Z-0146-2023 · Root cause: Packaging · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON OF A 120602FP FOGARTY CATHETER HAD A MALFUNCTION. THE SURGEON WAS PERFORMING AN ENDOSCOPIC CYST FENESTRATION THROUGH A SCOPE IN THE BRAIN. THE CATHETER ADVANCED WITHOUT A PROBLEM AND THE BALLOON WAS INFLATED BUT WOULD NOT DEFLATE FOR REMOVAL. SURGEON WAS FINALLY ABLE TO GET BALLOON DEFLATED HOWEVER IT STUCK TO SOME OF THE TISSUE AND HAD DIFFICULTY REMOVING THE CATHETER AS WELL. THE SURGEON WAS ABLE TO MANEUVER THE BALLOON AWAY FROM THE TISSUE TO FREE IT EVENTUALLY AND DID NOT REQUIRE ANY OTHER PROCEDURES OR IMAGING. THERE WAS NO HARM TO THE PATIENT. THE DEVICE IS AVAILABLE FOR RETURN ONCE INTERNAL INVESTIGATIONS HAVE BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17232262 ↗
• MalfunctionApr 28, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREP OF A MODEL 120602FP FOGARTY CATHETER, THE BALLOON WAS FOUND TO BE DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT. THE CATHETER CAME FROM LOT NUMBER 63850952. THE EDWARDS SALES REPRESENTATIVE SPOKE WITH THE FACILITYS OR DIRECTOR AND WAS INFORMED THAT THEY DISCOVERED THE SURGEON WAS OVER-INFLATING THE BALLOONS. THE REP SUGGESTED AN IN SERVICE AND FURTHER EDUCATION WAS DECLINED, AS THE OTHER SURGEONS AND OR STAFF DENIED HAVING ANY ISSUES WITH FOGARTY BALLOON INFLATION. THE SUSPECT CATHETER WAS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14239248 ↗
• MalfunctionDec 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SURGEON IN THE OPERATING ROOM HAD BEEN USING THE FOGARTY CATHETER AND THE BALLOON HAD COME OFF OF THE EQUIPMENT. THE PHYSICIAN WAS UNABLE TO RETRIEVE THIS BALLOON. PATIENT DEMOGRAPHICS WAS REQUESTED BUT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908865 ↗