Device recall
Z-1671-2013: RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN)…
FDA device recall · Class III · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1671-2013 |
|---|---|
| Recall event | 65347 |
| Product | RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia. |
| Product code | KNQ |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 10, 2014 |
| 510(k) numbers | K050232 |
| FEI number | 3005099803 |
At a glance
- 1–9 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