Cryogenic probe for cardiac ablation surgery — Class II medical device recall Z-0895-2015
Terminated recall by Atricure Inc, reported 2015-01-07, distributed nationwide. Affected product may have compromised sterility due to packaging defects. It was determined that some mishandl
| Recall number | Z-0895-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atricure Inc, West Chester, OH, United States |
| Recall initiated | 2014-11-21 |
| Classified | 2014-12-30 |
| Reported by FDA | 2015-01-07 |
| Terminated | 2015-07-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, CO, CZ, DE, DK, ES, FI, FR, GB, HK, IL, IT, JP, KR, LU, MY, NL, NO, SA, SE, TH, TR, TW, ZA |
| Quantity | 19,190 units |
| Reason classes | sterility, packaging |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0895-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.