Class II — Atricure Inc
| Recalling firm | ATRICURE, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| 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. |
| 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, COLOMBIA, TURKEY, Thailand, SOUTH KOREA, SAUDI ARABIA, TAIWAN, SOUTH AFRICA, and DENMARK. The af… |
| Initiated | 2014-11-21 |
| Classified | 2014-12-30 |
| Terminated | 2015-07-20 |
| Recall number | Z-0895-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Atricure Inc (Z-0895-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69713/
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