FOGARTY CORKSCREW 140808Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103042429), received between Apr 30, 2025 and Apr 30, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K233619, K901625); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Break; Burst Container or Vessel; Break; Burst Container or Vessel

  AS REPORTED, DURING USE IN PATIENT, THE LATEX COVERING THE FILAMENTS OF THIS FOGARTY CORKSCREW CATHETER WAS RIPPED. THERE IS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933623 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K233619, K901625. One submission often covers many models, so check the product and lot details in each record.

• Z-3077-2017 · Jul 6, 2017 · Terminated
  Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripher