Recall Z-1941-2019 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
| Date | Jul 16, 2019 (initiated Jun 17, 2019) |
| Status | Open, Classified |
| Reason | If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered. |
| Root cause | Use error |
| Action | On June 17, 2019, the firm notified its customers of the product issue via Urgent Medical Device Correction letters. Customers are to take the following immediate interim actions: " Ensure the IABP is plugged into an AC power outlet whenever possible during patient use to prevent the battery from depleting. " Ensure the IABP is plugged into an AC power outlet when the system is not in use. The batteries should be kept at a full charge even when the IABP is not in use. " When transporting patients within or between facilities, please refer to the IABP Operating Instructions Manual for recomme |
| Quantity | 16,656 |
| Distribution | Worldwide distribution. US Nationwide, AFGHANISTAN , HUNGARY , PANAMA , ALGERIA , ICELAND , PARAGUAY , ARGENTINA , INDIA , PERU , AUSTRALIA , INDONESIA , PHILIPPINES , AUSTRIA , IRAN , POLAND , AZERBAIJAN , IRAQ , PORTUGAL , BAHRAIN , IRELAND , QATAR , BANGLADESH , ISRAEL , ROMANIA , BELARUS , ITALY |
| 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 |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump Datascope Corp., Jul 2, 2015 |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case Datascope Corp., Jan 31, 2017 |
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump Datascope Corp., May 31, 2018 |