Device recall
Z-0464-2016: IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number…
FDA device recall · Class II · Boston Scientific Corp
Key facts
| Recall number (Z-number) | Z-0464-2016 |
|---|---|
| Recall event | 72721 |
| Product | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant… |
| Product code | OAD |
| Recalling firm | Boston Scientific Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2019 |
| PMA numbers | P020025, P020025S036 |
| 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