Datascope Corp. · Intra-Aortic Balloon Pump System (IABP)
Total Reports
184
Reports (30d)
6
Active Signals
1
Open Recalls
85
What the reports describe · Claripulse analysis
Waveform Issue During Use
request report, balloon iab, report issue, called emergency, line request
10
reports
Gas Loss Alarm Reported
request report, balloon iab, gas loss, report issue, program line
7
reports
Alarm Troubleshooting During Use
esp, esp line, personel, esp personel, reviewed
5
reports
Clotted Lumen with Waveform Loss
clotted, emergency support, program, support program, lumen
4
reports
Catheter Restriction Alarm
restriction alarm, request report, balloon iab, catheter restriction, iab catheter
4
reports
Unable to Monitor Arterial Waveform
unable, update timing, iab unable, unable update, timing alarm
2
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.
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
CARDIOSAVE HYBRID, TYPE B PLUG
Datascope Corp. · 12,800 reports
THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Thoratec Corporation · 7,148 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
