FOGARTY 12TLW1203FRecalls & reported problems
Edwards Lifesciences LLC · FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 3F 120CM · Class 2
All models of FOGARTY (32)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00690103177657), received between Feb 11, 2025 and Feb 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
1 other recall cover devices cleared under the same FDA submission (K240078, K892410); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.
MalfunctionFeb 11, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THERE WAS A FAILURE WITH A FOGARTY EMBOLECTOMY CATHETER. DURING USE, THE SURGEON INSERTED THE FOGARTY CATHETER THROUGH THE BRONCHOSCOPE INTO THE PATIENT'S CHEST CAVITY. WHEN THE BALLOON WAS ATTEMPTED TO BE INFLATED, THE SURGEON REALIZED THE BALLOON HAD POPPED. BIOPSY FORCEPS WERE USED TO RETRIEVE THE BALLOON, HOWEVER, THERE WERE NO BALLOON REMNANTS FOUND. THERE IS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21355569 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K240078, K892410. One submission often covers many models, so check the product and lot details in each record.
- Z-0238-2024 · Sep 7, 2023 · Open, ClassifiedFogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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