USFDA CDRH Medical Device Class I Recall Alert - Cook CloverSnare 4-Loop Vascular Retrieval Snare

Product:  CloverSnare 4-Loop Vascular Retrieval Snare

• Model Number VRS-6.0-90
• Manufacturing Dates: August 2012 – August 2013
• Distribution Dates: March 8, 2013 – July 1, 2014
• Complete Listing of Affected Lot Numbers
• 671 devices have been distributed nationwide

Use: The CloverSnare 4-Loop Vascular Retrieval Snare is used to manipulate and retrieve items in the cardiovascular system, such as temporary implanted devices. This includes inferior vena cava filters or broken devices (e.g., guidewires, coils, balloons, and catheters).

Recalling Firm: 
Cook Inc. 
750 N Daniels Way
Bloomington, Indiana 47404-9120

Reason for Recall: There is a potential for the snare loop to separate from the shaft.  If this occurs, the snare loop may travel through the vascular system and block blood vessels or become stuck in other organs, such as the heart and lungs. Additional intervention may be necessary to retrieve the separated snare loop from the patient.  This failure will also cause the device to stop working.  Four injuries have been reported.

The use of the affected product may cause serious adverse health consequences, including death.

On July 17, 2014, Cook Medical sent customers an Urgent Medical Device Recall letter informing them of the product, problem and actions to be taken.  The firm requested customers:

• Separate any affected unused products from inventory. 
• Collect and return all unused products to Cook Medical as soon as possible for credit.
• Complete and return the Recalled Product Reply Form to Cook Medical, separately or when returning the product.

About Class I Recalls

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.