The FDA has posted 7 enforcement recalls from Datascope Corp. since 2025, none of them Class I (most serious). Most recent report: Mar 25, 2026.
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.…
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Firm name as filed with the FDA: “Datascope Corp.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.