Cook CloverSnare 4-Loop Vascular Retrieval Snare Recalled for Tip Separation
Cook Inc. is recalling CloverSnare 4-Loop Vascular Retrieval Snares because the snare may separate from the distal tip of the wire.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used in the cardiovascular system where a mechanical failure (separation) poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cook Inc. is recalling the CloverSnare 4-Loop Vascular Retrieval Snare, model VRS-6.0-9.0. The product is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including wire guides, coils, balloons, catheters, and filters.
The recall is the result of six product complaints associated with the separation of the snare from the distal tip of the wire. A total of 696 devices were distributed, with 671 distributed nationwide and the remainder distributed internationally to Canada, Austria, Belgium, Denmark, Germany, Great Britain, Ireland, Italy, Spain, Sweden, and Switzerland.
Healthcare facilities and distributors should stop using the affected devices and contact Cook Inc. for further instructions. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- 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 object
- Manufacturer
- Cook Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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