The Recall Desk
ModerateFDA (Devices)·Z-1587-2026·Announced 2026-03-25

Cardiosave battery charging station left bay screw prevents full battery insertion

Datascope is recalling the Battery Charging Station, model 0998-00-0802, because a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The rubric places FDA Class III recalls at 1 or 2, and this fault affects one bay of an optional accessory charger rather than the pump itself, with the second bay unaffected.

Plain-English summary

Datascope Corp. is recalling the Battery Charging Station, model 0998-00-0802. About 28 units were distributed, 20 in the United States across 11 states and 8 outside it, to Australia, Hong Kong, Israel, Japan and Norway. The FDA has classified this recall as Class III.

The Battery Charging Station is an optional dual-bay charger used to charge 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 is not affected by this issue.

Affected product carries UDI 10607567111964, across 28 listed serial numbers.

Facilities can identify affected units by the model and serial numbers above, and may contact Datascope Corp. for further information.

The recalled product

Product
Battery Charging Station; Model: 0998-00-0802;
Manufacturer
Datascope Corp.
Category
Medical Device — Circulatory support accessory
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Related recalls

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