Device recall
Z-1117-2021: Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the…
FDA device recall · Class II · Medtronic Neurosurgery
Key facts
| Recall number (Z-number) | Z-1117-2021 |
|---|---|
| Recall event | 87157 |
| Product | Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US PER 90CM SM LOW 22017 B-M… |
| Product code | JXG |
| Recalling firm | Medtronic Neurosurgery |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K792007, K831678, K873247, K951258 |
| FEI number | 3015531529 |
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