Severity
Critical
FDA Devices recall · Reported September 3, 2014
This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.
Cook Inc. recalled CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterili… - a critical-severity action.
CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterili… was recalled by Cook Inc. in September 3, 2014. Reason: This remedial action is the result of six product complaints associated with separation of the snare from the…. Check the official notice for the remedy. Verify recall #Z-2243-2014 with the FDA Devices before acting.
The recall
Cook Inc. issued this critical-severity FDA Devices recall-This remedial action is the result of six product complaints associated with separation of the snare from the….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2243-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2243-2014) was formally reported on September 3, 2014, with the manufacturer initiating the action on July 17, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Cook Inc. is listed as the recalling firm, operating out of Bloomington, IN. Federal records list the affected scope as 696 devices total distribution (671 nationwide).
The documented reason for this recall is: This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire. Distribution data in the federal record shows the product reached: 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, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Critical
Affected scope
696 devices total distribution (671 nationwide)
Related Recalls
6
3 from same agency
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.
This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2243-2014 |
| Date reported | September 3, 2014 |
| Date initiated | July 17, 2014 |
| Recalling firm | Cook Inc. |
| Firm location | Bloomington, IN |
| Affected scope | 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, De… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 3, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.