Device recall
Z-1437-04: Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part #…
FDA device recall · Class II · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-1437-04 |
|---|---|
| Recall event | 29876 |
| Product | Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035; D-1078-63-S D5S06AL252RT 36A-07Q; D-1078-78-S 107878S N/A; D-1097-511-S 1097511S SW1097-511; D-1097-554-S D708DL002RT 36F-32Q. |
| Product code | DRF |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2005 |
| 510(k) numbers | K892265 |
| FEI number | 3003113629 |
At a glance
- 1–9 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