Device recall
Z-0896-2018: Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and…
FDA device recall · Class II · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-0896-2018 |
|---|---|
| Recall event | 78609 |
| Product | Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists… |
| Product code | LKK |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P860004 |
| FEI number | 2182207 |
At a glance
- None 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