Z-1587-2026Class III

Battery Charging Station; Model: 0998-00-0802

Name: Z-1587-2026 Battery Charging Station; Model: 0998-00-0802
Creator: Datascope Corp.
Published: 2026-02-06
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2026-02-06 / Open, Classified

FDA source

Datascope Corp. began a recall of Battery Charging Station; Model: 0998-00-0802 on 2026-02-06. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1587-2026
Classification: Class III
Status: Open, Classified
Initiated: 2026-02-06
Posted: 2026-03-19
Recalling firm: Datascope Corp.
Product: Battery Charging Station; Model: 0998-00-0802;
Product code: DSP System, Balloon, Intra-Aortic And Control
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 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 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.
Quantity in commerce: 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.
Product codes and 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1587-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1587-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-03-25	2026-03-19

Product code DSP

K112372Class IICardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC / cleared 2011-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)