Fogarty 120806FPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103205237), received between Oct 27, 2022 and Feb 7, 2023 — classified as 2 malfunctions.

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

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

1 other recall cover devices cleared under the same FDA submission (K193379); 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.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED WHILE PREPPING A FOGARTY CATHETER, MODEL 120806FP, LOT 63612683, THE BALLOON POPPED, OR HAD HOLES IN THE BALLOON. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315118 ↗
• MalfunctionOct 27, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A TEAM OF EW REPRESENTATIVES PERFORMED AN ON-SITE VISIT TO INVESTIGATE COMPLAINTS RELATED TO FOGARTY CATHETERS IN THE VASCUPOUCH. THE INITIAL INTERVIEW WITH HOSPITAL STAFF STATED THAT CATHETERS WERE STORED EITHER IN CENTRAL SUPPLY OR THE OR CORE. THE EDWARDS TEAM VISITED THE LOCATIONS WITHIN THE HOSPITAL WHERE CATHETERS WERE RECEIVED, STORED, AND ULTIMATELY USED. DURING THE FACILITY WALK THROUGH, IT WAS FOUND THAT THE CATHETERS WERE ALSO STORED IN TRAUMA OR 1. CATHETERS WERE TESTED IN LOCATIONS WHERE BOTH THE OUTER CORRUGATED PACKAGING HAD BEEN REMOVED AND PRIOR TO THE LOCATION OF THE REPORTED FAILURE, SPECIFICALLY, OR CORE AND TRAUMA OR 1. THE TEAM FOUND EVIDENCE OF XRAY IMAGING AND UV SANITIZATION BEING PRESENT IN TRAUMA OR 1, WHICH CORRESPONDS WITH OTHER FACILITY VISIT FINDINGS OF HIGH ENERGY SOURCES WHERE THE CATHETERS ARE STORED. THIS REPORT IS FOR ONE OF THE MODEL 120806FP, LOT 63852678 CATHETERS FROM TRAUMA OR 1 WHICH WAS NOTED TO HAVE A BALLOON THAT WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680194 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193379. One submission often covers many models, so check the product and lot details in each record.

• Z-0147-2023 · Oct 6, 2022 · Open, Classified
  Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP