Boston Scientific is conducting a removal of specific batches of rotawire drive and wireclip torquer after determining that a small number of pouches containing these products may have a weak seal, which could open during normal shipping and handling and thus compromise the sterile barrier. Use of a rotawire drive product from a package with a sterile barrier breach may present a risk of infection. The most serious health risk that could occur from use of a non-sterile rotawire drive is a post-procedure endocarditis or access site infection that could be managed with medical evaluation and treatment with oral or intravenous antibiotics. We have received one complaint related to this issue and there have been no patient harms or adverse events reported. Recall start date: Mar 8, 2022
RecallTracker