CLASS I Device recall · Reported 3 Sep 2014 · FDA Enforcement Report

CloverSnare 4-Loop Vascular Retrieval Snare recalled by Cook

Cook is recalling CloverSnare 4-Loop Vascular Retrieval Snare, distributed nationwide in the US. The recall was initiated on 17 Jul 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled696 devices total distribution (671 nationwide)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2243-2014
FDA event ID: 68914
Recalling firm: Cook, Bloomington, IN
Classification: Class I
Status: Terminated
Recall initiated: 17 Jul 2014
FDA classified: 27 Aug 2014
Reported: 3 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

17 Jul 2014	Recall initiated by company
27 Aug 2014	Classified by FDA	+41 days
3 Sep 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alaska Alabama Arizona California Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kentucky Louisiana Maryland Maine Michigan Minnesota Missouri

Questions about this recall

Is CloverSnare 4-Loop Vascular Retrieval Snare recalled?

Yes. Cook recalled CloverSnare 4-Loop Vascular Retrieval Snare on 17 Jul 2014. The recall is Class I and its status is Terminated. Recall number Z-2243-2014.

Why was it 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 lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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