Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway.
FDA Recall Z-0895-2015 · Posted 2014-12-30
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Recalling FirmAtricure Inc
Recall StatusTerminated
Product CodeGEH
Date Initiated2014-11-21
Date Terminated2015-07-20
Product Quantity19,190 units
Reason for Recall
Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.
Firm Action
AtriCure sent an Urgent Recall Notification letter dated November 21, 2014 with Acknowledgement Form to all affected customers. The letter identified the affected product, problem and actions to be taken. Distributors were instructed to notify their customers at once of this product recall. Customers were instructed to complete and return the enclosed Device Notification Acknowledgement Form as soon as possible. For any questions, call the toll-free Recall Hotline (844-783-5302), M-F, 8:00 AM-8:00 PM EST.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of: Canada, ITALY, NETHERLANDS, CZECH REPUBLIC, AUSTRIA, GERMANY, BELGIUM, Hong Kong, SPAIN, UNITED KINGDOM (GREAT BRITAIN), UNITED KINGDOM, JAPAN, FRANCE, FINLAND, LUXEMBOURG, Korea, SWITZERLAND, SWEDEN, Malaysia, ISRAEL, NORWAY, AUSAtralia, COLOMBIA, TURKEY, Thailand, SOUTH KOREA, SAUDI ARABIA, TAIWAN, SOUTH AFRICA, and DENMARK. The affected product was also distributed to 17 government consignees.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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