Devices

Device Recall TriActiv FX Embolic Protection System 7F

Model / Serial
Catalog numbers 60040-02 and 60040-03. Lot numbers 49709 exp 3/31/07, 51844 exp 5/31/07, 52822 exp 7/31/07, 53209 exp 5/31/07, 53252 exp 7/31/07, 54264 exp 7/31/07, 54276 exp 11/30/07, 49912 exp 3/30/07, 50952 exp 5/31/07, 51714 exp 7/31/07, 52488 exp 5/31/07, and 54248 exp 11/30/07.
Product Classification
General and Plastic Surgery Devices
Device Class
Unclassified
Implanted device?
No
Distribution
Worldwide, including USA and Germany.
Product Description
TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.
Manufacturer
Kensey Nash Corp
1 Event
- Recall of Device Recall TriActiv FX Embolic Protection System 7F

Manufacturer

Kensey Nash Corp

Manufacturer Address
Kensey Nash Corp, 735 Pennsylvania Dr, Exton PA 19341-1130
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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