Device recall
Z-0593-2019: St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170…
FDA device recall · Class II · St. Jude Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0593-2019 |
|---|---|
| Recall event | 81461 |
| Product | St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY St. Jude Medical Plano, TX Instructions For Use: Lead and… |
| Product code | MHY |
| Recalling firm | St. Jude Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 13, 2022 |
| PMA numbers | P140009, P140009S001, P140009S037 |
| FEI number | 1627487 |
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