Recall -- Firm Press Release
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CloverSnare™ 4-Loop Vascular Retrieval Snare Recall
FOR IMMEDIATE RELEASE - August 19, 2014 - On July 10, 2014, Cook Medical initiated a recall of 696 of its CloverSnare™ 4-Loop Vascular Retrieval Snare devices. The device was recalled because of a potential for the loop to separate from the shaft, resulting in loss of device function, potential for embolization of snare fragments and the potential need for intervention to retrieve the separated snare.
Customers have been advised to return the recalled devices to Cook Medical. The recall affects products manufactured between August 2012 and August 2013 and distributed between March 8, 2013 and July 1, 2014.
The following product has been recalled:
Model: CloverSnare™ 4-Loop Vascular Retrieval Snare
Model Number: VRS-6.0-9.0
In six cases, customers reported separation of the loop snare from the shaft during use. The separation was caused by the application of lateral force to the snare in an effort to change the shape of the device. In four cases of separation, medical intervention to retrieve the separated snare was required.
Cook Medical has notified all customers of the recall by letter and has arranged for affected devices to be returned. In addition, Cook Medical has notified the FDA of this action. The recall affects customers in the United States, Canada, Austria, Belgium, Denmark, Germany, Great Britain, Ireland, Italy, Spain, Sweden and Switzerland. Cook reports that the problem occurred only in these specific lots. There have been no known problems in the devices manufactured after that time.
Customers with questions may contact Cook Medical at 800-457-4500 or by email at CustomerrelationsNA@cookmedical.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178