FOGARTY 120403FSPRecalls & reported problems
Edwards Lifesciences LLC · FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 40CM · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Oct 6, 2022Open, Classified
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
Z-0146-2023 · Root cause: Packaging · FDA record ↗
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.