Device recall
Z-1322-2021: EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5…
FDA device recall · Class II · EPIX THERAPEUTICS, INC
Key facts
| Recall number (Z-number) | Z-1322-2021 |
|---|---|
| Recall event | 87412 |
| Product | EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013 |
| Product code | OAE |
| Recalling firm | EPIX THERAPEUTICS, INC |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P200028 |
| FEI number | 3015180993 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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