Device recall
Z-1702-2017: The Medtronic StrataMR adjustable valves and shunts are designed to provide…
FDA device recall · Class I · Medtronic Neurosurgery
Key facts
| Recall number (Z-number) | Z-1702-2017 |
|---|---|
| Recall event | 76595 |
| Product | The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level… |
| Product code | JXG |
| Recalling firm | Medtronic Neurosurgery |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 19, 2017 |
| 510(k) numbers | K152700 |
| 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