FOGARTY 12TLW806FRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00690103043549), received between Dec 21, 2023 and Sep 8, 2025 — classified as 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Burst Container or Vessel; Material Fragmentation; Burst Container or Vessel; Material Fragmentation

  AS REPORTED, DURING USE IN PATIENT, THE BALLOON OF THIS EMBOLECTOMY FOGARTY CATHETER BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER EVALUATION RESULTS, THE BALLOON WAS FOUND TO BE RUPTURED IN THE MIDDLE AREA. THE EDGES OF LATEX DID NOT APPEARED TO MATCH AT THE RUPTURED REGION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992994 ↗
• MalfunctionJul 17, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING TEST PRIOR TO USE IN PATIENT, THE BALLOON OF THIS EMBOLECTOMY FOGARTY CATHETER BURST. THE DEVICE WAS RECEIVED FOR EVALUATION, THE BALLOON WAS RUPTURED NEAR THE PROXIMAL WINDING 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 22528713 ↗
• MalfunctionApr 25, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING TESTING OF THIS FOGARTY CATHETER, THE BALLOON BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE EDGES OF LATEX DID NOT MATCH AT THE RUPTURED LOCATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907150 ↗
• MalfunctionJan 24, 2025Failure to Deflate; Failure to Deflate

  AS REPORTED, DURING USE IN PATIENT OF THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON DID NOT DEFLATE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21227870 ↗
• MalfunctionDec 21, 2023Break; Break

  IT WAS REPORTED THAT A MODEL 12TLW806F FOGARTY CATHETER BROKE IN HALF DURING A PROCEDURE. CUSTOMER WAS ABLE TO SUCCESSFULLY REMOVE CATHETER WITHOUT AN ADDITIONAL PROCEDURE. NO FURTHER TROUBLESHOOTING WAS ATTEMPTED, A NEW FOGARTY WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378874 ↗

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