FOGARTY 620404FRecalls & reported problems
Edwards Lifesciences LLC · FOGARTY OCCLUSION CATHETER 4F 40CM · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103043723), received between Jul 22, 2025 and Jul 22, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Slipped” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Slipped1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025Device Slipped; Material Split, Cut or Torn; Device Slipped; Material Split, Cut or Torn
AS REPORTED, AFTER INSERTION OF THIS FOGARTY OCCLUSION CATHETER, THE BALLOON INFLATED DEFORMED WITH RUPTURE ON THE ATTACHMENT POINT. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED AND UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563050 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.