Device recall
Z-0900-2014: Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0900-2014 |
|---|---|
| Recall event | 67298 |
| Product | Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire. |
| Product code | ITX |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 29, 2014 |
| 510(k) numbers | K080272 |
| FEI number | 2939204 |
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