CARDIOSAVE HYBRID, TYPE B PLUG Adverse Events: FDA MAUDE Data
Datascope Corp. · Intra-Aortic Balloon Pump System (IABP)
Total Reports
13,507
Reports (30d)
176
Active Signals
0
Open Recalls
85
What the reports describe · Claripulse analysis
Most commonly reported problems
Internal Communication Error Malfunction
pressure, status, safety, engineer fse, blood
240
reports
Autofill Failure Alarm During Use
15
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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.
Evidence
Related research
Radakovic D, et al. · Life (Basel, Switzerland) · 2022
Mork C, et al. · CJC open · 2021
Jiang Y, et al. · International journal of biological sciences · 2022
Kodaka M, et al. · JA clinical reports · 2020
Shimahara Y, et al. · Interdisciplinary cardiovascular and thoracic surgery · 2023
Citations indexed from PubMed.
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