Cook Inc. recalls CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supp

Recalled September 3, 2014 · FDA recall Z-2243-2014 · Cook

Hazard

This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire. · FDA Class I

Units

696 devices total distribution (671 nationwide)

Sold at

Worldwide Distribution - USA including AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TX, UT, VA, WA, WI, WV and Internationally to: Canada, Austria, Belgium, Denmark, Germany, Great Britain, Ireland, Italy, Spain, Sweden, and Switzerland.

Description

This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.

Product

CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including but not limited to, wire guides, coils, balloons, catheters, and filters.

Manufacturer(s)

Cook Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →