Device recall
Z-1011-2009: Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome…
FDA device recall · Class II · Boston Scientific Corp
Key facts
| Recall number (Z-number) | Z-1011-2009 |
|---|---|
| Recall event | 50861 |
| Product | Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 30 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3513. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla… |
| Product code | LQR |
| Recalling firm | Boston Scientific Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 22, 2009 |
| 510(k) numbers | K946358 |
| FEI number | 1828132 |
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