Device recall
Z-2091-2008: Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile. The…
FDA device recall · Class II · Boston Scientific Corp
Key facts
| Recall number (Z-number) | Z-2091-2008 |
|---|---|
| Recall event | 48437 |
| Product | Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable… |
| Product code | GEI |
| Recalling firm | Boston Scientific Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 16, 2008 |
| 510(k) numbers | K982556 |
| FEI number | 1828132 |
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