Device recall
Z-2418-2011: Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135…
FDA device recall · Class I · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-2418-2011 |
|---|---|
| Recall event | 58405 |
| Product | Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF / Catalog No. 51805, UPN / Product No. H749518050, Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 94538 This catheter is intended for ultrasound examination of coronary intravascular… |
| Product code | DQO |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 30, 2012 |
| 510(k) numbers | K050577, K063312 |
| FEI number | 3002095335 |
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