Device recall
Z-0814-2017: MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120 S61CM D66CM GLOBAL Catalog…
FDA device recall · Class II · Oscor, Inc.
Key facts
| Recall number (Z-number) | Z-0814-2017 |
|---|---|
| Recall event | 75785 |
| Product | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120 S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. |
| Product code | DYB |
| Recalling firm | Oscor, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 26, 2019 |
| 510(k) numbers | K101497, K122958 |
| FEI number | 1035166 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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