Device recall
Z-1164-2024: Medtronic Duet External Drainage and Monitoring System, Interlink Injection…
FDA device recall · Class I · Medtronic Neurosurgery
Key facts
| Recall number (Z-number) | Z-1164-2024 |
|---|---|
| Recall event | 93919 |
| Product | Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume. |
| Product code | PCB |
| Recalling firm | Medtronic Neurosurgery |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3015531529 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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