FOGARTY 120805FRecalls & reported problems
Edwards Lifesciences LLC · FOGARTY ARTERIAL EMBOLECTOMY CATHETER 5F 80CM · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103043310), received between Jan 18, 2024 and Mar 20, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER BURST. THE DEVICE WAS RECEIVED FOR EVALUATION AND BALLOON AND DISTAL WINDINGS WERE MISSING. PROXIMAL WINDINGS WERE FOUND TO BE UNRAVELED. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21650914 ↗MalfunctionJan 18, 2024Material Separation; Material Separation
IT WAS REPORTED THAT AN EMBOLECTOMY CATHETER BALLOON RUPTURED DURING A THROMBECTOMY PROCEDURE. PART OF THE BALLOON BECAME SUSPENDED IN THE PATIENTS FISTULA. PATIENT CONDITION IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18540383 ↗
Other CATHETER, EMBOLECTOMY devices
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- Indigo System CATRXKITPenumbra, Inc. · Catheter, Embolectomy1 death339 reports
- Fogarty 120804FPEdwards Lifesciences LLC · Catheter, Embolectomy1 recall1 death200 reports
- LeMaitre Embolectomy Catheter 1651-88Lemaitre Vascular, Inc. · Catheter, Embolectomy1 recall161 reports
- FOGARTY 120404FPEdwards Lifesciences LLC · Catheter, Embolectomy1 recall61 reports
- 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.