Datascope Cardiosave IABP Battery Charging Station recalled for defective left bay
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.
From the FDA notice · Read the official notice ↗ · All Datascope recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Battery Charging Station; Model: 0998-00-0802;
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 28 units (20 US, 8 OUS)
- Illnesses reported
- None reported
- Manufactured in
- 1300 Macarthur Blvd, N/A, Mahwah, NJ, United States
- Classification
- Class III
- Recall number
- Z-1587-2026
In the FDA's words
- Description
- Battery Charging Station; Model: 0998-00-0802; 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. 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; 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. Affected quantity: 28 units (20 US, 8 OUS)
- 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.