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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire."
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…
- 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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