Devices

Device Recall Fogarty Fortis Arterial Embolectomy Catheter

Model / Serial
Lots # 58320651, 58320652, 58323511, 58323512, 58323513, 58326739, 58326740, 58326741, 58329130, and 58329131
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
International Distribution --- including countries of Austria, Belgium, Bulgaria, Switzerland, Czech republic, Germany, Denmark, United Kingdom, Italy, Luxembourg, Netherlands, Sweden, Slovak Republic, South Africa, and Taiwan.
Product Description
Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter || Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.
Manufacturer
Edwards Lifesciences, LLC
1 Event
- Recall of Device Recall Fogarty Fortis Arterial Embolectomy Catheter

Manufacturer

Edwards Lifesciences, LLC

Manufacturer Address
Edwards Lifesciences, LLC, 1 Edwards Way, Irvine CA 92614-5688
Manufacturer Parent Company (2017)
Edwards Lifesciences Corporation
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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