Device recall
Z-1401-2017: AngioJet Ultra 5000 A Console:Foot Switch Material number (U PN) 105650…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1401-2017 |
|---|---|
| Recall event | 76400 |
| Product | AngioJet Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid inflow and outflow, provides the operator with Ultra System set-up prompts, total infused saline… |
| Product code | MCX |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 22, 2019 |
| PMA numbers | P980037 |
| FEI number | 2939204 |
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