Z-2243-2014 Class I Terminated
FDA device recall Z-2243-2014 was initiated by Cook Inc. on Jul 17, 2014 and is designated Class I. 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. The recall status is terminated (terminated Jun 16, 2015). Affected quantity: 696 devices total distribution (671 nationwide).
Recall Details
- Product Type
- Devices
- Report Date
- Sep 3, 2014
- Initiation Date
- Jul 17, 2014
- Termination Date
- Jun 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 696 devices total distribution (671 nationwide)
Product Description
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.
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.
Distribution Pattern
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2243-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026