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U.S. Department of Health and Human Services

Class 2 Device Recall cryoICE cryoablation probe (CRYO2)

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  Class 2 Device Recall cryoICE cryoablation probe (CRYO2) see related information
Date Initiated by Firm November 21, 2014
Date Posted December 30, 2014
Recall Status1 Terminated 3 on July 20, 2015
Recall Number Z-0895-2015
Recall Event ID 69713
510(K)Number K082074  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product 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.
Code Information The following batch numbers are affected by this recall: 26500 27831 27959 28248 28472 28474 28475 28910 28911 29337 29461 29525 29788 29926 29933 29934 30358 30359 30618 30810 31401 31402 32037 32200 32210 32211 32771 32790 33047 33261 33262 33340 33527 33528 33581 33582 33631 33661 33663 33918 34283 34284 34586 34587 34793 34852 34853 35167 35177 35247 35307 35308 35682 35683 36279 36292 36686 37005 37207 37558 37655 37686 37855 38007 38171 38433 38533 38636 38719 38869 38994 39087 39196 39285 39424 39475 39503 39504 39694 39780 39867 39943 40067 40189 40288 40398 40534 40640 40709 40826 40986 41105 41302 41414 41517 41597 41737 41850 41909 41982 42046 42141 42466 42470 42567 42612 42719 42836 42932 43047 43182 43281 43354 43485 43604 43691 43827 43833 43953 44096 44215 44368 44491 44612 44781 44936 45048 45130 45268 45277 45378 45390 45492 45612 45628 45654 45715 45842 45845 45854 45973 46272 46353 46466 46569 46770 46852 46974 47067 47195 47298 47408 47540 47677 47851 47905 47937 48085 48174 48288 48394 48679 48684 48700 48906 48953 49012 49042 49179 49378 49477 49478 49502 49503 49699 49717 49815 49816 49830 49831 50017 50018 50210 50211 50335 50336 50472 50473 50554 50555 50700 50701 50859 50860 51079 51080 51258 51259 51348 51349 51490 51631 51632 51773 51774 51901 51902 52018 52019 52197 52278 52279 52342 52461 52462 52575 52576 52730 52731 52849 52850 52951 52952 53144 53168 53405 53406 53423 53424 53607 38994A 39087A 39475A 39475AA 39867A 40709A 40709B 42836A 43182A 43182B 43281A
Recalling Firm/
Manufacturer		 Atricure Inc
6217 Centre Park Drive
West Chester OH 45069
For Additional Information Contact Recall Toll-free Hotline
844-783-5302
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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, COLOMBIA, TURKEY, Thailand, SOUTH KOREA, SAUDI ARABIA, TAIWAN, SOUTH AFRICA, and DENMARK. The affected product was also distributed to 17 government consignees.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEH and Original Applicant = ATRICURE, INC.
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