Datascope Corp. · Intra-Aortic Balloon Pump System (IABP) · First cleared Jun 1989
Total Reports
408
Reports (30d)
2
Active Signals
1
Open Recalls
85
What the reports describe · Claripulse analysis
Battery Not Charging During Use
battery, balloon pump, patient involved, cardiosave intra, pump iabp
3
reports
Autofill Failure Alarm
balloon pump, autofill, autofill failure, failure alarm, pump iabp
2
reports
Helium Leak Issue
pump iabp, helium, balloon pump, leak, cardiosave intra
1
reports
Unit Not Switching On During Check
battery, routine, patient involved, routine check, patient reported
1
reports
Unit Not Turning On Before Use
balloon pump, patient involved, cardiosave, cardiosave intra, pump iabp
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Feb 6, 2026 · Open, Classified
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.
Jan 23, 2026 · Open, Classified
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Jan 23, 2026 · Open, Classified
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Nov 4, 2025 · Open, Classified
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Nov 4, 2025 · Open, Classified
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Oct 23, 2025 · Open, Classified
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Evidence
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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