FDA Device recall Z-0895-2015
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation su…
- FDA Device
- Class II
- terminated
- Published 2015-01-07
On 2015-01-07 the FDA classified a Class II recall of Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation su… by Atricure, citing 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 d….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0895-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-21 |
| Published | 2015-01-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Atricure |
| Distribution | US |
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
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.
Identifiers
| code_info | The following batch numbers are affected by this recall: 26500 27831 27959 28248 28472 28474 28475 28910 28911…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 4562 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0895-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.