Device recall
Z-1209-2015: IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material…
FDA device recall · Class I · Boston Scientific Corp
Key facts
| Recall number (Z-number) | Z-1209-2015 |
|---|---|
| Recall event | 70506 |
| Product | IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a… |
| Product code | OAD |
| Recalling firm | Boston Scientific Corp |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 21, 2017 |
| FEI number | 3001236349 |
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