Recall Z-1587-2026
Datascope Corp. · initiated February 6, 2026
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Battery Charging Station; Model: 0998-00-0802;
Codes / lots: Model: 0998-00-0802; UDI: 10607567111964; Serial Numbers: 200019347EAI, 200019847EAI, 200019447EAI, 210018625EAI, 210017925EAI, 210017525EAI, 210018425EAI, 210020144EAI, 210020944EAI, 210022544EAI, 210020244EAI, 210022144EAI, 210020044EAI, 210020544EAI, 210021344EAI, 210023244EAI, 210018025EAI, 210019025EAI, 210021144EAI, 210021044EAI, 210022344EAI, 210019225EAI, 210019125EAI, 210018525EAI, 210022844EAI, 200017647EAI, 210019725EAI, 210022744EAI;
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 notification. Return the completed form to recallresponses.grc@getinge.com. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.
Details
- Recall number
- Z-1587-2026
- Initiated
- February 6, 2026
- Posted by FDA
- March 19, 2026
- Product code
- DSP – System, Balloon, Intra-Aortic And Control
- 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.
- Recalling firm
- Datascope Corp., Mahwah, NJ