Recall Z-1386-2017 ยท DSP System, Balloon, Intra-Aortic And Control
Maquet Datascope Corp - Cardiac Assist Division
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
| Date | Dec 23, 2016 |
| Status | Terminated |
| Reason | Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped. |
| Root cause | Device Design |
| Action | Maquet contacted their customers via letter on 12/23/16 and additional customers identified were notified on 1/10/17 and issued a recall letter/return response form. The letter identified the affected product problem and actions to be taken. Customers were instructed to complete and return the response form via fax to 1-973-629-1518 or email to cardiosavebattery@getinge.com |
| Quantity | 8000 |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |