Devices

Device Recall TriActiv System Procedure Kit 340 cm

Model / Serial
Lot number 47303 exp 9/30/06
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.
Product Description
TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using femoral approach.
Manufacturer
Kensey Nash Corp
1 Event
- Recall of Device Recall TriActiv System Procedure Kit 340 cm

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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