Recall Z-2243-2014— Cook Inc.

Name: FDA recall Z-2243-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-17

Class I · Terminated

Class I FDA medical device recall by Cook Inc., initiated 2014-07-17, terminated 2015-06-16. It names one FDA 510(k) clearance: K112185. 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.. Reason: This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire..

Recalling firm: Cook Inc.
Classification: Class I
Status: Terminated
Initiated: 2014-07-17
Terminated: 2015-06-16
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K112185 — FOURSNARE VASCULAR RETRIEVAL SNARECook, Inc.·cleared 2011-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.