Datascope Corp.
FDA adverse event reports naming Datascope Corp. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: DATASCOPE CORP..
- Total reports
- 26,550
- Deaths
- 498
- Injuries
- 875
- Malfunctions
- 25,081
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- System, Balloon, Intra-Aortic And ControlDSP26,016
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX108
- Tubing, Pump, Cardiopulmonary BypassDWE82
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF63
- Introducer, CatheterDYB63
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT42
- Dc-Defibrillator, Low-Energy, (Including Paddles)LDD26
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI25
- Oxygenator, Cardiopulmonary BypassDTZ22
- Wire, Guide, CatheterDQX17
Recent recalls
- 2026-03-19Open, ClassifiedUnder Investigation by firm
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.
- 2026-03-03Open, ClassifiedUnder Investigation by firm
CS100 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.
- 2026-03-03Open, ClassifiedUnder Investigation by firm
CS300 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.
- 2025-12-16Open, ClassifiedProcess change control
Cardiosave Hybrid
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
- 2025-12-16Open, ClassifiedProcess change control
Cardiosave Rescue
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
- 2025-12-11Open, ClassifiedComponent design/selection
Cardiosave 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.
- 2025-12-11Open, ClassifiedComponent design/selection
Cardiosave 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.
- 2024-11-05Open, ClassifiedError in labeling
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
There is discrepant labeling on the inner and outer packaging of the device.
- 2024-09-20Open, ClassifiedSoftware design
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
- 2024-09-20Open, ClassifiedSoftware design
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
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