Device recall
Z-1770-2020: Rhythm Xience Flextra Steerable Introducer with Lancer Integrated…
FDA device recall · Class II · Acutus Medical Inc
Key facts
| Recall number (Z-number) | Z-1770-2020 |
|---|---|
| Recall event | 85197 |
| Product | Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly |
| Product code | DYB |
| Recalling firm | Acutus Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2021 |
| 510(k) numbers | K170373 |
| FEI number | 3012120746 |
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