FOGARTY 120403FPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103205084), received between Jun 30, 2022 and Jun 30, 2022 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 6, 2022Open, Classified

   Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

   Z-0146-2023 · Root cause: Packaging · FDA record ↗

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.

• MalfunctionJun 30, 2022Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USE OF A MODEL 120403FP FOGARTY EMBOLECTOMY CATHETER, THE BALLOON DID NOT INFLATE WHEN TESTED. A TEAR WAS NOTED ON THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE DATE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14879857 ↗