Z-2243-2014Class I

CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package...

Name: Z-2243-2014 CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package...
Creator: Cook Inc.
Published: 2014-07-17
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2014-07-17 / Terminated / root cause: design

FDA source

Cook Inc. began a recall of 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... on 2014-07-17. FDA classified it as Class I and 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2243-2014
Classification: Class I
Status: Terminated
Initiated: 2014-07-17
Posted: 2014-08-27
Terminated: 2015-06-16
Recalling firm: Cook Incorporated
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 objects, including but not limited to, wire guides, coils, balloons, catheters, and filters.
Product code: MMX Device, Percutaneous Retrieval
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.
Root cause tag: design
FDA root cause: Device Design
Action: Cook Medical sent an Urgent Medical Device Recall letter dated July 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the attached list of affected products and lot numbers shipped to their account, and quarantine any affected product that remains unused. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. Complete the attached Recalled Product Reply Form and return to Cook Medical either with the product or separately. Customers were asked to report any Adverse Event to Cook Medical Customer Relations at 800-457-4500 or 1-812-339-2235.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2243-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2243-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-27

Product code MMX

K112185Class IIFoursnare Vascular Retrieval SnareCook, Inc. / cleared 2011-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)