FOGARTY 12TLW807FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103043556), received between Jun 21, 2024 and Apr 15, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• MalfunctionApr 15, 2026Burst Container or Vessel

  AS REPORTED, DURING USE IN A PATIENT FOR THE REMOVAL OF AN INTRAVASCULAR THROMBUS AND EMBOLI, THE FRONT-END BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER RUPTURED AND COULD NOT BE INFLATED. AS PER CUSTOMER'S OPINION THIS MIGHT CAUSED AN INTERRUPTION DURING SURGERY AND INCREASED SURGICAL RISK. THE DEVICE WAS IMMEDIATELY DISCONTINUED, AND ANOTHER CATHETER WAS USED, FUNCTIONING NORMALLY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24881411 ↗
• MalfunctionDec 10, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, BEFORE USE IN PATIENT, WHEN TRYING TO INFLATE THE BALLOON OF THIS EMBOLECTOMY FOGARTY CATHETER WITH CONTRAST MEDIUM, IT BROKE AND THERE WERE MISSING PIECES. AS PER CUSTOMER OPINION, THE BALLOON LATEX MISSING PIECES COULD HAVE BEEN ENTERED INTO THE BLOOD STREAM IF THE DEVICE HAD BEEN INSERTED INTO THE PATIENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891768 ↗
• MalfunctionJun 21, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER PLACING THIS FOGARTY CATHETER FOR AORTIC OCCLUSION DURING AN EMERGENCY INTERVENTION AFTER A CAR ACCIDENT WHERE PATIENT SUFFERED AORTIC RUPTURE, TRAUMATIC RESPIRATORY AND CARDIAC ARREST, ALONG WITH EXTENSIVE SOFT TISSUE AVULSION INJURIES IN THE LOWER LIMBS AND PERINEUM, AND COMMINUTED FRACTURES IN THE LOWER LIMBS, THE BALLOON BURST AFTER INJECTING 3 ML OF SALINE. THEN, THE CATHETER WAS REMOVED AND THORACIC CARDIAC COMPRESSION AND AORTIC REPAIR WERE PERFORMED TO OBSTRUCT THE BLOOD FLOW OF THE DESCENDING AORTA. THERE WAS NO PATIENT INJURY RELATED TO BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581890 ↗

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