CARDIOSAVE HYBRID TYPE D PLUG Adverse Events: FDA MAUDE Data
Datascope Corp. · Intra-Aortic Balloon Pump System (IABP) · First cleared Jul 2015
Total Reports
261
Reports (30d)
9
Active Signals
2
Open Recalls
85
What the reports describe · Claripulse analysis
Most commonly reported problems
Unit Fails to Power Up
check cardiosave, check, routine, cardiosave intra, power
6
reports
Autofill Failure Alarm Triggered
autofill, iabp autofill, autofill failure, cardiosave intra, failure alarm
5
reports
Battery Malfunction During Routine Check
battery, maintenance, batteries, charging, cardiosave intra
3
reports
General Malfunction Reported
reported cardiosave, reported use, blood, cardiosave intra, iabp malfunctioned
2
reports
Flickering Screen During Routine Check
display, routine, screen, involved cardiosave, cardiosave intra
1
reports
Helium Leak in Pump System
helium, reported cardiosave, involved cardiosave, leak, cardiosave intra
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
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.
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