Class 1 Device Recall CloverSnare 4Loop Vascular Retrieval Snare

• Date Initiated by Firm: July 17, 2014
• Date Posted: August 27, 2014
• Recall Status: Terminated on June 16, 2015
• Recall Number: Z-2243-2014
• Recall Event ID: 68914
• 510(K)Number: K112185
• Product Classification: Device, percutaneous retrieval - Product Code MMX
• 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.
• Code Information: Model Number(s): VRS-6.0-9.0 Lot numbers: 3583416, 3583418, 3583422, 3583424, 3583426, 3583428, 3583430, 3583432, 3583434, 3583436, 3583440, 3583442, 3583452, 3583456, 3583458, 3583462, 3583464, 3583466, 3583468, 3583470, 3583472, 3583474, 3583476, 3583478, 3583480, 3583482, 3583484, 3583486, 3583488, 3583490, 3583492, 3583494, 3583496, 3583498, 3583500, 3583502, 3583504, 4293921, 4293923, 4293925, 4293927, 4319573, 4319575, 4319577, 4319579, 4319581, 4319583, 4319585, 4319587, 4319589, 4319591, 4572365, 3583418X, 3583430X, 3583442X, 3583442XX, 3583464XXX, 3583480XX, and 3583486X.
• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Departme; 812-339-2235
• Manufacturer Reason for Recall: This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.
• FDA Determined 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. Customers were asked to report any Adverse Event to Cook Medical Customer Relations at 800-457-4500 or 1-812-339-2235.
• Quantity in Commerce: 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, and Switzerland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MMX and Original Applicant = COOK, INC.