Official recall record
Battery Charging Station; Model: 0998-00-0802;
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-02-06
- Country of alert
- United States
- Alert level
- Class III
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10607567111964
- Brand on record
- Datascope Corp.
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2024-08-08 · US FDA — Medical Devices
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra
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