Device recall
Z-0211-2016: RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation…
FDA device recall · Class I · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0211-2016 |
|---|---|
| Recall event | 72409 |
| Product | RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque… |
| Product code | MCX |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 13, 2017 |
| PMA numbers | P900056 |
| FEI number | 3002095335 |
At a glance
- None 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