Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–17 of 17 recalls
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.…
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potent…
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potent…
Catheter manufactured at the incorrect length.
Sterility assurance; microcatheter inner packaging may contain incomplete seal.