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.
Reported: September 3, 2014 Initiated: July 17, 2014 #Z-2243-2014
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 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.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cook Inc.. Units affected: 696 devices total distribution (671 nationwide).
Why was this product recalled? ▼
This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 3, 2014. Severity: Critical. Recall number: Z-2243-2014.
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