Manta Adverse Events: FDA MAUDE Data
TELEFLEX INCORPORATED · Vascular Hemostasis/Closure Device · First cleared Feb 2019 · 16 device variants grouped
Total Reports
1,538
Reports (30d)
4
Active Signals
9
Open Recalls
1
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.
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