Recall Z-2243-2014
Cook Inc. · initiated July 17, 2014
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: 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.
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 taken
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.
Details
- Recall number
- Z-2243-2014
- Initiated
- July 17, 2014
- Posted by FDA
- August 27, 2014
- Terminated
- June 16, 2015
- Product code
- MMX – Device, Percutaneous Retrieval
- 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, and Switzerland.
- Recalling firm
- Cook Inc., Bloomington, IN