Device recall
Z-0738-2021: Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only…
FDA device recall · Class II · Medtronic Neurosurgery
Key facts
| Recall number (Z-number) | Z-0738-2021 |
|---|---|
| Recall event | 86988 |
| Product | Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. |
| Product code | JXG |
| Recalling firm | Medtronic Neurosurgery |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K110560 |
| 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