Boston Scientific (NYSE:BSX) is initiating a voluntary select recall of its Agile biliary RX fully covered stents over issues with device migrations, according to a recently posted field safety notice.
The Marlborough, Mass.-based company said that it became aware of a higher than anticipated rate of stent migrations, which can require additional interventions and re-stenting “due to lack of stricture resolution,” according to the posting.
Boston Scientific said that it doesn’t recommend the removal of existing implanted devices which are still performing adequately, but advised medical professionals to monitor patients already implanted with the stents according to standard of care.
The voluntary recall affects all batch numbers of Agile biliary RX fully covered stents with model numbers M00586000, M00586010, M00586020, M00586060, M00586070 and M00586080 and GTIN numbers 08714729950219, 08714729950226, 08714729950264, 08714729950271 and 08714729950288, according to the release.
The company suggested that medical professionals stents in inventory immediately discontinue use of them and remove and return all affected devices.
Earlier this month, Boston Scientific touted 12-month data for its Vici venous stent in people with significant obstructions in the illiofemoral venous outflow tract.
The post Boston Scientific pulls Agile biliary stent on migration reports appeared first on MassDevice.
from MassDevice http://bit.ly/2DJOlRe
Cap comentari:
Publica un comentari a l'entrada