FOGARTY 120803FRecalls & reported problems
Edwards Lifesciences LLC · FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 80CM · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00690103043280), received between Mar 3, 2020 and Sep 19, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (3 reports).
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 Vessel3
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body Embolism1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, DURING TESTING OF THIS FOGARTY EMBOLECTOMY CATHETER, AN AIR LEAKAGE FROM THE BALLOON WAS NOTICED. WHEN TESTING AGAIN, THE BALLOON BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE SPRING TIP WIRE WAS VISIBLE. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23093707 ↗MalfunctionMay 28, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT, DURING USE, WHEN WITHDRAWING THIS FOGARTY CATHETER FOR THE SECOND TIME, THE BALLOON BURST. THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22102451 ↗InjuryApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, WHEN TRAWLING DURING A POPLITEAL ARTERY EMBOLECTOMY OF THIS FOGARTY EMBOLECTOMY CATHETER, THE BALLOON DISLODGED IN THE VESSEL. THE BALLOON COULD NOT BE RETRIEVED USING A NEW FOGARTY EMBOLECTOMY CATHETER.
Patient problems: Foreign Body Embolism
MAUDE report 21933800 ↗MalfunctionSep 24, 2024Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE FOGARTY ARTERIAL EMBOLECTOMY 120803F BALLOON TIP BURST IN A PATIENT DURING A PROCEDURE. NO PATIENT INJURY WAS REPORTED AND NO DEMOGRAPHICS WERE AVAILABLE. THERE WILL BE NO PRODUCT RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20297195 ↗MalfunctionMar 3, 2020Break
WE ARE PERFORMING A FEMORAL POPLITEAL THROMBECTOMY AND USING #3 FOGARTY CATHETER, THE TIP OF THE CATHETER BROKE OFF IN THE PATIENT'S ARTERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9779695 ↗
Other CATHETER, EMBOLECTOMY devices
- Indigo System CAT6Penumbra, Inc. · CATHETER, EMBOLECTOMY2 deaths408 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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