FOGARTY 12TLW803FRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00690103043501), received between Dec 21, 2022 and Apr 17, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Material Fragmentation

  AS REPORTED, DURING PREOPERATIVE TESTING OF THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON WAS FOUND TO BE RUPTURED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON WAS FOUND COMPLETELY BROKEN IN THE MIDDLE AREA; THE LATEX EDGES AT THE RUPTURE SITE DID NOT MATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24908018 ↗
• MalfunctionFeb 4, 2026Failure to Deflate

  AS REPORTED, DURING DEVICE PREP, THE BALLOON OF A FOGARTY THRU-LUMEN CATHETER COULD NOT BE DEFLATED. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264181 ↗
• MalfunctionJan 2, 2026Material Fragmentation

  AS REPORTED, BEFORE USE IN PATIENT, THIS FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER HAD A BALLOON LEAKAGE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER EVALUATION RESULTS, THE BALLOON WAS FOUND TO BE RUPTURED IN THE MIDDLE AREA. THE EDGES OF LATEX DID NOT APPEAR TO MATCH AT THE RUPTURED REGION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943537 ↗
• MalfunctionDec 17, 2025Failure to Deflate; Failure to Deflate

  AS REPORTED DURING TESTING BEFORE USE IN A PATIENT THE BALLOON OF THIS FOGARTY CATHETER COULD NOT BE DEFLATED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830353 ↗
• MalfunctionOct 22, 2025Degraded; Material Fragmentation; Degraded; Material Fragmentation

  AS REPORTED, DURING PREOPERATIVE INSPECTION OF THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON FAILED TO INFLATE. VISUAL EXAMINATION REVEALED SIGNS OF LATEX DETERIORATION. IN ADDITION, A FLUID TEST WAS PERFORMED AND FEW TINY DROPS WERE OBSERVED LEAKING. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON WAS RUPTURED AT THE CENTRAL AREA; THE BALLOON EDGES DID NOT APPEAR TO MATCH UP AT THE RUPTURED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355454 ↗
• MalfunctionSep 18, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED WHEN THE BALLOON OF THIS FOGARTY CATHETER WAS INFLATED JUST AFTER INSERTING INTO THE PATIENT THE BALLOON BURST. THE CUSTOMER STATED THAT IT WAS UNLIKELY THAT VASCULAR CALCIFICATION WAS THE CAUSE OF THIS BALLOON BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23087333 ↗
• MalfunctionSep 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING PROCEDURE, THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER WAS DETACHED FROM THE CATHETER AND CAUSED SALINE LEAKAGE. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036620 ↗
• MalfunctionJul 16, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING USE OF THIS FOGARTY EMBOLECTOMY CATHETER, A SALINE LEAKAGE WAS FOUND. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER EVALUATION RESULTS, BALLOON WAS FOUND TO BE RUPTURED AT THE CENTRAL AREA. THE EDGES OF LATEX DID NOT APPEAR TO MATCH UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518955 ↗
• MalfunctionJul 7, 2025Burst Container or Vessel; Material Split, Cut or Torn; Burst Container or Vessel; Material Split, Cut or Torn

  AS REPORTED, DURING A LOWER LIMB ARTERY INCISION AND THROMBECTOMY SURGERY, THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER WAS BROKEN. AS PER PRODUCT EVALUATION FINDINGS, THE BALLOON WAS FOUND TO BE RUPTURED IN THE MIDDLE AREA. THE EDGES OF LATEX DID NOT MATCH AT THE RUPTURED REGION. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22423893 ↗
• MalfunctionJun 11, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING FLUSHING BEFORE USE OF THIS FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER, BALLOON WAS DAMAGED AND LEAKING. IN ADDITION, THERE WAS LEAKAGE THROUGH THE CATHETER BODY BACKFORM. EVENT WAS SOLVED REPLACING WITH NEW UNIT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION. AS PER EVALUATION RESULTS, THE BALLOON WAS FOUND TO BE RUPTURED IN THE MIDDLE AREA. THE EDGES OF LATEX DID NOT MATCH AT THE RUPTURED REGION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182373 ↗
• MalfunctionApr 3, 2025Degraded; Degraded

  AS REPORTED, DURING TESTING OF THIS FOGARTY EMBOLECTOMY CATHETER, A BALLOON LEAKAGE WAS FOUND; THEREFORE, IT COULD NOT BE INFLATED. THE DEVICE WAS NOT USED ON PATIENT. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE EDGES OF THE BALLOON LATEX DID NOT APPEAR TO MATCH UP AT THE RUPTURED AREA. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760164 ↗
• MalfunctionJan 27, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF THIS EMBOLECTOMY FOGARTY CATHETER WAS DAMAGED. THE DEVICE WAS RECEIVED FOR EVALUATION. THE BALLOON WAS RUPTURED IN THE MIDDLE AREA AND THE EDGES OF LATEX DID NOT MATCH AT THE RUPTURED REGION. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21239220 ↗
• MalfunctionNov 11, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE 12TLW803F FOGARTY CATHETER DID NOT DEFLATE AT THE TIME OF THE CATHETER REMOVAL. AN ADDITIONAL INCISION WAS PERFORMED 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 20657537 ↗
• MalfunctionNov 4, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE WERE MULTIPLE PREVIOUS EVENTS WHERE THE BALLOON WOULD NOT DEFLATE. THE DOCTOR WOULD FILL THE BALLOON UP WITH CONTRAST AND THEN WHEN ATTEMPTING TO DEFLATE, IT WOULD NOT DEFLATE. THE DOCTOR WOULD THEN DILUTE IT AND TRY TO DEFLATE IT, AND IT WILL NOT GO DOWN. THERE WAS NO ALLEGATION OF PATIENT INJURY. DEVICES NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605260 ↗
• MalfunctionNov 4, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. THE DOCTOR WAS FILLING IT UP WITH CONTRAST AND THEN WHEN THEY TRIED TO DEFLATE IT, IT DOES NOT DEFLATE. THEY WILL THEN DILUTE IT AND TRY TO DEFLATE IT, AND IT WILL NOT GO DOWN. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604360 ↗
• MalfunctionJul 15, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, BEFORE USE IN PATIENT, WHEN INFLATING THIS FOGARTY CATHETER, THE BALLOON BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE BALLOON EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED REGION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740264 ↗
• MalfunctionMay 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT TWO PROBLEMS OCCURRED IN THE SAME 12TLW803F FOGARTY CATHETER DURING USE. THE GATE VALVE BECAME UNABLE TO BE OPENED AND THE GUIDEWIRE DID NOT PASS THROUGH THE CATHETER. THESE ISSUES WERE RESOLVED BY REPLACING THE CATHETER WITH A NEW ONE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914784 ↗
• MalfunctionFeb 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON OF THE FOGARTY, MODEL 12TLW803F FROM LOT 64394458, CATHETER RUPTURED DURING USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375992 ↗
• MalfunctionDec 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON OF MODEL 12TLW803F FOGARTY CATHETER FROM LOT 64394458 DID NOT INFLATE DURING THE INFLATION TEST BEFORE USE IN THE PATIENT. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW ONE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PER THE PRODUCT EVALUATION FINDINGS, THE BALLOON RUPTURED, HOWEVER IT WAS UNABLE TO DETERMINE IF THE EDGES MATCHED UP. THERE WAS NO DETERIORATION FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16024524 ↗

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