Device recall
Z-0617-2013: Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm…
FDA device recall · Class III · St Jude Medical Inc
Key facts
| Recall number (Z-number) | Z-0617-2013 |
|---|---|
| Recall event | 63855 |
| Product | Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum. |
| Product code | DYB |
| Recalling firm | St Jude Medical Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 12, 2013 |
| 510(k) numbers | K964518 |
| FEI number | 2126673 |
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