Device recall
Z-0895-2015: Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek…
FDA device recall · Class II · Atricure Inc
Key facts
| Recall number (Z-number) | Z-0895-2015 |
|---|---|
| Recall event | 69713 |
| 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… |
| Product code | GEH |
| Recalling firm | Atricure Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 20, 2015 |
| 510(k) numbers | K082074 |
| FEI number | 3011706110 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database