FOGARTY 12TLW404FRecalls & reported problems
Edwards Lifesciences LLC · FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER, 4F 40CM · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103043464), received between Feb 11, 2025 and Aug 26, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel2
- Detachment of Device or Device Component1
- Failure to Deflate1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Failure to Deflate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50454702 ↗MalfunctionSep 11, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
AS REPORTED, DURING SURGERY, THE BALLOON OF THIS FOGARTY EMBOLECTOMY CATHETER BURST. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. AS PER PRODUCT EVALUATION FINDINGS, PART OF THE CATHETER TIP, BALLOON LATEX, DISTAL BUSHING, AND DISTAL WINDING WERE COMPLETELY DETACHED FROM THE CATHETER BODY. AS CONFIRMED, NO ADDITIONAL INTERVENTION WAS NEEDED IN ORDER TO RETRIEVE THE PIECES DETACHED AND THE PATIENT DID NOT SUFFER ANY HURT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23026557 ↗MalfunctionFeb 11, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE BALLOON OF THIS FOGARTY CATHETER RUPTURED WHEN IT WAS INFLATED AND PULLED TO REMOVE THE BLOOD CLOT AT THE ANASTOMOTIC SITE DURING USE. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356571 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.