TELEFLEX INCORPORATED · Intra-Aortic Balloon Pump System (IABP) · First cleared Oct 1998 · 234 device variants grouped
Total Reports
4,724
Reports (30d)
97
Active Signals
25
Open Recalls
34
What the reports describe · Claripulse analysis
IAB Not Fully Unwrapping
states iab, additional information, current, patient current, states
54
reports
IABP Not Holding Charge
patient current, states, current condition, condition reported, information states
42
reports
Blood Found in Helium Pathway
current, patient current, current condition, catheter, removed
20
reports
Helium Leakage Alarm After Insertion
consequence, patient current, consequence reported, injury consequence, reported fine
20
reports
Damaged Sheath Found During Insertion
sheath, current condition, condition reported, injury consequence, reported fine
17
reports
Balloon Not Inflating Issue
states iab, current, additional information, information states, reported fine
16
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
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.
Evidence
Echocardiographic Evaluation for Safe and Complete Transcatheter Left Atrial Appendage Closure.
Miura M, et al. · 2025
Diaphragm Training in Patients With Left Ventricular Assist Devices: A Narrative Review of Rehabilitation and Clinical Implications.
Bordoni B, et al. · 2025
A Drop of Danger: A Subtle Sign of an Entrapped Pulmonary Artery Catheter.
Ram H. · 2026
Efficacy and safety of empiric transcatheter arterial embolization for acute arterial upper gastrointestinal bleeding: A tertiary-care, single-center experience.
Gönüllü E, et al. · 2026
Complications of catheter-directed interventions in acute pulmonary embolism: a narrative expert review with guidance on management.
García-Martí G, et al. · 2026
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
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. 25 active signals detected right now.
Get Early AccessUnderstanding this data
