Manta Adverse Events: FDA MAUDE Data
TELEFLEX INCORPORATED · Vascular Hemostasis/Closure Device · First cleared Feb 2019 · 16 device variants grouped
Total Reports
1,546
Reports (30d)
1
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Incomplete Retraction of Closure Device
provided arteriotomy, using pre, arteriotomy closure, prostyle devices, prostyle
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Apr 12, 2023 · Open, Classified
The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.
Evidence
Related research
Outcome of a Prospective Registry to Evaluate the Performance of the MANTA Vascular Closure Device in EVAR Patients.
Goeteyn J, et al. · Annals of vascular surgery · 2026
Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures
Zvonimir Krajcer, et al. · Journal of Endovascular Therapy · 2020
Full percutaneous decannulation of VA-ECMO using MANTA<sup>®</sup> and Femoseal<sup>®</sup> devices: a propensity-score based study.
Berg E, et al. · Critical care (London, England) · 2026
Citations indexed from PubMed.
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