Manta Adverse Events: FDA MAUDE Data
TELEFLEX INCORPORATED · Vascular Hemostasis/Closure Device · First cleared Feb 2019 · 16 device variants grouped
Total Reports
1,548
Reports (30d)
1
Active Signals
6
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Foot Failure During Pre-Close
pre close, pre placed, close technique, prostyle, prostyle device
3
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 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
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
Percutaneous Femoral Arterial Closure Following Decannulation of Venoarterial Extracorporeal Membrane Oxygenation Using the MANTA Vascular Closure Device.
Batchelor RJ, et al. · Heart, lung & circulation · 2025
Performance of the MANTA Vascular Closure Device in Endovascular Aortic Procedures: A Single-Center Experience.
Katelenets M, et al. · Annals of vascular surgery · 2025
Efficacy, safety, and complications of manta vascular closure device in VA-ECMO decannulation: A systematic review and meta-analysis.
Nunes-Carvalho J, et al. · The journal of vascular access · 2025
Citations indexed from PubMed.
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