Datascope Corp.
7 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Datascope Corp. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-25FDA-DeviceClass IIIBattery 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.
- 2026-03-11FDA-DeviceClass IICS300 IABP. Software Version CS300 IABP C.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
- 2026-03-11FDA-DeviceClass IICS100 IABP. Software Version CS100 IABP Q.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
- 2025-12-24FDA-DeviceClass IIICardiosave Rescue
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
- 2025-12-24FDA-DeviceClass IIICardiosave Hybrid
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
- 2025-12-17FDA-DeviceClass IICardiosave Rescue. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
- 2025-12-17FDA-DeviceClass IICardiosave Hybrid. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
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