Battery Charging Station recallZ-1587-2026 · Datascope Corp. · initiated Feb 6, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Datascope Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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 [email protected]. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.
Recall details
- Recall number
- Z-1587-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 6, 2026
- Posted by the FDA
- Mar 19, 2026
- Recalling firm
- Datascope Corp.
- Quantity
- 28 units (20 US, 8 OUS)
- Product code
- DSP
- FDA submissions
- K112372
- 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.
Product description
Battery Charging Station; Model: 0998-00-0802;
Code information (models, lots, serial numbers)
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;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CARDIOSAVE BATTERY CHARGING STATION 0998-00-0802Datascope Corp. · System, Balloon, Intra-Aortic And Control1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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