Recall Z-1587-2026 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Battery Charging Station; Model: 0998-00-0802;
| Date | Mar 19, 2026 (initiated Feb 6, 2026) |
| Status | Open, Classified |
| Reason | The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue. |
| Root cause | Under Investigation by firm |
| Action | On February 6, 2026 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken by the customer: Our records indicate that you may have one or more Battery Charging Station(s) in your facility. Please forward this information to all current Battery Charging Station users within your facility. " If you are currently using one of the affected Battery Charging Stations, please follow the instructions in the Battery Charging Instructions section of this letter. " Complete and sign the attached Response Form to acknowledge that you have received and understand this notifica |
| Quantity | 28 units (20 US, 8 OUS) |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, DC, GA, IL, IN, MD, MI, NC, TX, WA, WI and the countries of Australia, Hong Kong, Israel, Japan, Norway. |
| 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 |