FOGARTY 120803FSRecalls & reported problems
Edwards Lifesciences LLC · FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 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 00690103043297), received between Oct 17, 2025 and Oct 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel1
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.
MalfunctionOct 17, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, UPON OPENING OF PACKAGE OF THIS FOGARTY ARTERIAL EMBOLECTOMY CATHETER, BALLOON WAS FOUND BURST LEAVING INTERNAL WIRE EXPOSED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23320743 ↗
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- Indigo System CAT6KIT-APenumbra, Inc. · Catheter, Embolectomy109 reports
- LeMaitre Embolectomy Catheter e1651-88Lemaitre Vascular, Inc. · Catheter, Embolectomy2 recalls4 reports
- Indigo System CAT8XTORQ115Penumbra, Inc. · CATHETER, EMBOLECTOMY2 deaths98 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.