Recall Z-3043-2017 ยท MAV Syringe, Balloon Inflation
Boston Scientific Corporation
Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
| Date | Jun 15, 2017 |
| Status | Terminated |
| Reason | Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated their recall on 06/15/2017 by letter delivered by Fed Ex in the US, on 06/15-29/2017 in the Americas delivered by Courier, email and hand delivery, on 06/16/2017 in Europe by DHL, on 06/16-19/2017 in the Arab Emirates and East Asia by email and hand delivery and on 06/136/2017 in Japan by hand delivery. In the notice, the firm described the problem and requested the following action: 1. Immediately check the inventory and identify whether there are products with UPNs and lot numbers affected by the recall. 2. Inspect the device tray in the area highlighted a |
| Quantity | 305,779 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955869 | SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE Scimed Life Systems, Inc., Mar 22, 1996 |