Device recall
Z-0662-2025: Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM…
FDA device recall · Class I · Medtronic Neurosurgery
Key facts
| Recall number (Z-number) | Z-0662-2025 |
|---|---|
| Recall event | 95725 |
| Product | Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS 27795 EXACTA 100ML CATH… |
| Product code | GWM |
| Recalling firm | Medtronic Neurosurgery |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K200456 |
| FEI number | 3015531529 |
At a glance
- 1–9 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