ARROW IABP Adverse Events: FDA MAUDE Data
TELEFLEX INCORPORATED · Intra-Aortic Balloon Pump System (IABP) · First cleared Oct 1998 · 238 device variants grouped
Total Reports
5,227
Reports (30d)
124
Active Signals
2
Open Recalls
34
What the reports describe · Claripulse analysis
Most commonly reported problems
Internal Communication Error Malfunction
pressure, status, safety, engineer fse, blood
195
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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