Recall Z-0895-2015 ยท GEH Unit, Cryosurgical, Accessories
Atricure Inc
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 conductio
| Date | Dec 30, 2014 (initiated Nov 21, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging process control |
| 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. |
| Quantity | 19,190 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082074 | ATRICURE CRYO1 CRYO-ABLATION PROBE AtriCure, Inc., Mar 2, 2009 |