Recall Z-1248-2016 ยท DSP System, Balloon, Intra-Aortic And Control
Maquet Datascope Corp - Cardiac Assist Division
Cardiosave Hybrid and rescue IABP
| Date | Dec 16, 2015 |
| Status | Terminated |
| Reason | Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates. |
| Root cause | Other |
| Action | Maquet sent an "Urgent - Medical Device Field Correction Notice and Response form dated December 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed of the issues and provided corrective actions. Customers are asked to completed the attached response form in order to return to 1-973-629-1518, or via email to cardiosavescroll@maquet.com. Questions can be directed 1-800-777-4222, option 3, Monday through Friday 8 am-6 pm. EST. |
| Quantity | 1243 units US; 1107 units OUS |
| Distribution | Worldwide Distribution- Nationwide Distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112372 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP Cardiac Assist, Maquet Cardiovascular, LLC, Sep 15, 2011 |