FOGARTY 12TLW403FRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103043457), received between Nov 27, 2024 and Oct 20, 2025 — classified as 4 malfunctions.

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

• MalfunctionOct 20, 2025Burst Container or Vessel; Fluid/Blood Leak; Material Fragmentation; Burst Container or Vessel; Fluid/Blood Leak; Material Fragmentation

  AS REPORTED, DURING PREOPERATIVE PROCESS, WHEN FILLING THE BALLOON OF THIS EMBOLECTOMY FOGARTY CATHETER, SALINE LEAKAGE WAS OBSERVED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER EVALUATION RESULTS, THE BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA. THE RUPTURED EDGES DID NOT APPEAR TO MATCH AT THE RUPTURED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334307 ↗
• MalfunctionMar 13, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING USE WITH A FOGARTY THRU LUMEN EMBOLECTOMY VASCULAR CATHETER, WHILE THE USER WAS PULLING THE THROMBUS WITH THE INFLATED BALLOON, THE BALLOON BURST. THE TIP OF THE CATHETER BECAME BROKEN. AN ADDITIONAL INCISION WAS REQUIRED TO REMOVE THE FRAGMENTS. ALL THE FRAGMENTS COULD NOT BE COMPLETELY REMOVED. THERE WAS NO PATIENT INJURY OR COMPLICATIONS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597725 ↗
• MalfunctionDec 9, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THE 12TLW403F FOGARTY CATHETER RUPTURED BEFORE USE. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879562 ↗
• MalfunctionNov 27, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THIS FOGARTY CATHETER RUPTURED DURING USE. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20794215 ↗

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