FDA-Device2026-03-25Class IIIPROCESSING DEFECT

Datascope Cardiosave IABP Battery Charging Station recalled for defective left bay

OTHERNationwide distributionMedical devices

What this means

Datascope's Battery Charging Station (Model 0998-00-0802) for Cardiosave IABP batteries has a protruding screw in the left bay that can prevent certain batteries from inserting fully and charging properly. The right bay works normally. This affects 28 units distributed in select U.S. states and international locations.

Check if your Battery Charging Station matches the recalled model number 0998-00-0802
If you have one of the affected serial numbers, try using only the right battery bay for charging
Contact Datascope or Getinge for repair or replacement instructions

The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

28 units (20 US, 8 OUS)

Manufactured in

1300 Macarthur Blvd, N/A, Mahwah, NJ, United States

Products

Battery Charging Station; Model: 0998-00-0802;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1587-2026

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