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Rotawire drive guidewire and wireclip torquer
Official notice
14 Mar 2022
Last checked
14 Mar 2022
An official Health Canada notice concerns Rotawire drive guidewire and wireclip torquer. 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 Published 2022-03-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63998
Official notice
2022-03-14
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Brand: Boston Scientific, Rotawire Drive Guidewire And Wireclip Torquer.
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Documents, notices & source
See the official notice and source documents for full details.
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