Datascope Corp. · Intra-Aortic Balloon Pump System (IABP)
Total Reports
12,800
Reports (30d)
214
Active Signals
1
Open Recalls
85
What the reports describe · Claripulse analysis
Gas Loss Alarm During Use
loss iab, regarding gas, circuit alarm, iab circuit, cardiosave regarding
201
reports
Gas Loss Alarm Occurred
gas loss, iabp gas, alarm occurred, loss alarm, occurred harm
69
reports
Alarm Troubleshooting During Use
esp, esp line, personel, esp personel, reviewed
61
reports
Gas Loss Alarm Reported
cardiosave regarding, request report, gas loss, regarding gas, loss alarm
57
reports
Battery Not Charging Issue
cardiosave regarding, battery charging, request report, report issue, line request
51
reports
Touch Screen Not Working
balloon pump, screen, cardiosave, cardiosave intra, pump iabp
50
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.
Keep exploring
Impella
Abiomed, Inc. · 38,616 reports
HVAD Pump Implant Kit
MEDTRONIC, INC. · 37,256 reports
HeartMate 3
Thoratec Corporation · 22,317 reports
HeartMate
Thoratec Corporation · 16,109 reports
THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Thoratec Corporation · 7,148 reports
ARROW IABP
TELEFLEX INCORPORATED · 4,724 reports
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.
Get Early AccessUnderstanding this data
