Recall Z-2243-2014 ยท MMX Device, Percutaneous Retrieval
Cook Inc.
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.
| Date | Aug 27, 2014 (initiated Jul 17, 2014) |
| Status | Terminated |
| Reason | This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire. |
| Root cause | Device Design |
| Action | Cook Medical sent an Urgent Medical Device Recall letter dated July 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the attached list of affected products and lot numbers shipped to their account, and quarantine any affected product that remains unused. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. Complete the attached Recalled Product Reply Form and return to Cook Medical either with the product or separately. |
| Quantity | 696 devices total distribution (671 nationwide) |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112185 | FOURSNARE VASCULAR RETRIEVAL SNARE Cook, Inc., Nov 2, 2011 |