Battery Charging Station; Model: 0998-00-0802;
FDA Recall Z-1587-2026 · Posted 2026-03-19
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Recalling FirmDatascope Corp.
Recall StatusOpen, Classified
Product CodeDSP
Date Initiated2026-02-06
Product Quantity28 units (20 US, 8 OUS)
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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