Device recall
Z-1156-2010: CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System…
FDA device recall · Class II · Boston Scientific Corp
Key facts
| Recall number (Z-number) | Z-1156-2010 |
|---|---|
| Recall event | 53463 |
| Product | CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050, manufactured by Barnant ThermoFisher Scientific, Barrington, IL. Distributed by Boston Scientific Corporation, San Jose, CA. The Chilli Cooled Ablation System is indicated for cardiac… |
| Product code | LPB |
| Recalling firm | Boston Scientific Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2010 |
| PMA numbers | P980003 |
| FEI number | 3001236349 |
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