FOGARTY 62080814FRecalls & reported problems
Edwards Lifesciences LLC · FOGARTY OCCLUSION CATHETER 8/14F 80CM · 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 00690103043747), received between Mar 24, 2025 and Mar 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Degraded” (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
- Degraded1
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.
MalfunctionMar 24, 2025Degraded; Degraded
AS REPORTED, DURING USE IN PATIENT, THE BALLOON OF THIS FOGARTY CATHETER DID NOT INFLATE. THERE WAS NO ALLEGATION OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21683232 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.