Device recall
Z-1748-2013: Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1748-2013 |
|---|---|
| Recall event | 65303 |
| Product | Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial… |
| Product code | OOY |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2013 |
| PMA numbers | P080032 |
| FEI number | 3005099803 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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