FOGARTY 120404FPRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00690103205107), received between Jun 28, 2022 and Mar 27, 2025 — classified as 61 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (45 reports).

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 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Burst Container or Vessel; Degraded; Burst Container or Vessel; Degraded

  AS REPORTED, WHILE TESTING BEFORE USE IN PATIENT, THE BALLOON OF THIS FOGARTY ARTERIAL EMBOLECTOMY CATHETER BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE CATHETER WAS RECEIVED FOR EVALUATION AND THE BALLOON LATEX APPEARED DETERIORATED. MULTIPLE CRACKS AND RUPTURES EVIDENT ON THE BALLOON LATEX AND THE BALLOON EDGES DID NOT APPEAR TO MATCH UP AT THE RUPTURED REGIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708293 ↗
• MalfunctionMar 27, 2025Burst Container or Vessel; Degraded; Burst Container or Vessel; Degraded

  AS REPORTED, WHILE TESTING BEFORE USE IN PATIENT, THE BALLOON OF THIS FOGARTY ARTERIAL EMBOLECTOMY CATHETER BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE CATHETER WAS RECEIVED FOR EVALUATION AND THE BALLOON LATEX APPEARED DETERIORATED. MULTIPLE CRACKS AND RUPTURES EVIDENT ON THE BALLOON LATEX AND THE BALLOON EDGES DID NOT APPEAR TO MATCH UP AT THE RUPTURED REGIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708112 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT A BALLOON TIP BROKE OFF AN EMBOLECTOMY CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY. ATTEMPTS WERE MADE FOR FURTHER DETAILS OF EVENT. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387877 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT A BALLOON TIP BROKE OFF AN EMBOLECTOMY CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY. ATTEMPTS WERE MADE FOR FURTHER DETAILS OF EVENT. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387122 ↗
• MalfunctionDec 21, 2023Break; Break

  IT WAS REPORTED THAT A BALLOON TIP BROKE OFF AN EMBOLECTOMY CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY. ATTEMPTS WERE MADE FOR FURTHER DETAILS OF EVENT. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379506 ↗
• MalfunctionOct 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE TIP OF A VASCULAR CATHETER CAME OFF BEFORE PATIENT USE. CUSTOMER WAS UNSURE IF THE BALLOON AND WINDINGS WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17971738 ↗
• MalfunctionJul 20, 2023Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture

  IT WAS REPORTED, THAT A 120805F FOGARTY CATHETER HAD A BALLOON RUPTURE. DURING A RIGHT FEMORAL CUTDOWN THROMBOEMBOLECTOMY WITH ANGIO. THEY WERE USING DIFFERENT SIZES OF FOGARTY CATHETERS. EACH TIME THEY INJECTED THE APPROPRIATE AMOUNT OF FLUID, THE BALLOON WOULD BURST. THE STAFF DID GET A CATHETER TO WORK, AFTER GOING THROUGH SO MANY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368034 ↗
• MalfunctionApr 25, 2023Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT BEFORE USE WITH A PATIENT WHILE BEING TESTED, THIS FOGARTY CATHETER (MODEL: 120404FP, LOT: 63612519) DID NOT INFLATE. THERE IS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807408 ↗
• MalfunctionApr 25, 2023Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT BEFORE USE WITH A PATIENT WHILE BEING TESTED, THE BALLOON ON THIS FOGARTY CATHETER (MODEL: 120404FP, LOT: 63613958) DID NOT INFLATE. THERE IS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807322 ↗
• MalfunctionMar 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH MW5114988 THAT THE BALLOON OF AN EMBOLECTOMY CATHETER DID NOT REMAIN INTACT DURING PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583747 ↗
• MalfunctionMar 19, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOONS ON TWO MODEL 120404FP FOGARTY CATHETERS HAD HOLES PRIOR TO INFLATION. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR AN ADDITIONAL CATHETER RETURNED BY THE CUSTOMER FOR AN UNKNOWN REASON. THE CATHETER WAS FROM LOT 63484847, WHICH IS NOT THE SAME LOT THAT THE ORIGINALLY REPORTED CATHETERS CAME FROM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570557 ↗
• MalfunctionMar 19, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOONS ON TWO FOGARTY CATHETERS MODEL 120404FP, LOT 63523031, HAD HOLES PRIOR TO INFLATION. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR ONE OF THE REPORTED CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570537 ↗
• MalfunctionFeb 22, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF THE FOGARTY CATHETER 120404FP FROM LOT 63776293 COULD NOT MAINTAIN ITS INFLATION DURING THE INFLATION TEST BEFORE USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420279 ↗
• MalfunctionJan 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF A FOGARTY CATHETER, MODEL 120404FP, HAD HOLES IN IT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16242662 ↗
• MalfunctionJan 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF A FOGARTY CATHETER, MODEL 120404FP, HAD HOLES IN IT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16242632 ↗
• MalfunctionJan 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF A FOGARTY CATHETER, MODEL 120404FP, HAD HOLES IN IT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16242491 ↗
• MalfunctionJan 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF A FOGARTY CATHETER, MODEL 120404FP, HAD HOLES IN IT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16242340 ↗
• MalfunctionJan 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF A FOGARTY CATHETER, MODEL 120404FP, HAD HOLES IN IT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241765 ↗
• MalfunctionJan 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON ON A FOGARTY CATHETER, MODEL 120404FP FROM LOT 63735746, HAD HOLES IN IT, IT WAS DISCOVERED DURING THE INFLATION TEST. THERE WAS NO ALLEGATION OF PATIENT INJURY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153888 ↗
• MalfunctionJan 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON ON A FOGARTY CATHETER, MODEL 120404FP FROM LOT 63735746, HAD HOLES IN IT, IT WAS DISCOVERED DURING THE INFLATION TEST. THERE WAS NO ALLEGATION OF PATIENT INJURY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153862 ↗
• MalfunctionJan 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON ON A FOGARTY CATHETER, MODEL 120404FP FROM LOT 63735746, HAD HOLES IN IT, IT WAS DISCOVERED DURING THE INFLATION TEST. THERE WAS NO ALLEGATION OF PATIENT INJURY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153851 ↗
• MalfunctionDec 5, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF THE FOGARTY CATHETER MODEL NUMBER 120404FP FROM LOT 64052436, DID NOT INFLATE DURING THE INFLATION TEST BEFORE USE IN THE PATIENT. BLOOD WAS FOUND ON THE DEVICE, BUT NO INFECTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15917045 ↗
• MalfunctionDec 5, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF THE FOGARTY CATHETER, MODEL NUMBER 120404FP FROM LOT NUMBER 63464776, DID NOT INFLATE AFTER THE CATHETER WAS INSERTED INTO THE PATIENT. THE CATHETER WAS REPLACED WITH ANOTHER ONE. THE ISSUE WAS OBSERVED IN TWO CONSECUTIVE CATHETERS. PLEASE REFER TO 2022-19487-01 FOR THE COMPLAINT OF THE FIRST CATHETER. THE SALES REP CONFIRMED THAT THE PATIENT HAD NO INFECTION. THE PROCEDURE WAS COMPLETED WITHOUT A PROBLEM BY USING THE THIRD CATHETER. NO NEW ACCESS SITE WAS REQUIRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916950 ↗
• MalfunctionDec 5, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BALLOON OF THE FOGARTY CATHETER, MODEL NUMBER 120404FP FROM LOT NUMBER 63464776, DID NOT INFLATE AFTER THE CATHETER WAS INSERTED INTO THE PATIENT. THE CATHETER WAS REPLACED WITH ANOTHER ONE. THE ISSUE WAS OBSERVED IN TWO CONSECUTIVE CATHETERS. PLEASE REFER TO 2022-19487-02 FOR THE COMPLAINT OF THE SECOND CATHETER. THE SALES REP CONFIRMED THAT THE PATIENT HAD NO INFECTION. THE PROCEDURE WAS COMPLETED WITHOUT A PROBLEM BY USING THE THIRD CATHETER. NO NEW ACCESS SITE WAS REQUIRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916880 ↗
• MalfunctionNov 15, 2022Material Fragmentation; Material Puncture/Hole; Material Fragmentation; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO USE AND DURING USE, THE BALLOON OF FOGARTY MODEL 120404FP, LOT 63856326, HAD A HOLE PRESENT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15801031 ↗