ARROW IABP Adverse Events: FDA MAUDE Data
TELEFLEX INCORPORATED · Intra-Aortic Balloon Pump System (IABP) · First cleared Oct 1998 · 235 device variants grouped
Total Reports
4,969
Reports (30d)
120
Active Signals
25
Open Recalls
34
What the reports describe · Claripulse analysis
Most commonly reported problems
Catheter Replacement After Inflation Issue
removed replaced, iab, catheter, condition reported, reported fine
67
reports
Pump Stopped During Patient Use
current, patient current, current condition, condition reported, reported fine
45
reports
Balloon Incomplete Inflation After Insertion
catheter, catheter patient, catheter inserted, fine catheter, reported fine
30
reports
Helium Leak Alarm After Catheter Insertion
helium, catheter, catheter inserted, inserted, reported fine
15
reports
Multiple Helium Loss Alarms
alarms, loss, helium, patient current, iab
15
reports
Unit Fails to Power Up
check cardiosave, check, routine, cardiosave intra, power
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
Apr 29, 2024 · Open, Classified
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
Apr 29, 2024 · Open, Classified
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
Apr 29, 2024 · Open, Classified
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
Oct 17, 2022 · Open, Classified
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Oct 17, 2022 · Open, Classified
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Oct 17, 2022 · Open, Classified
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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