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The U.S. Food and Drug Administration is updating the communication “Early Alert: Percutaneous Catheter Issue from Boston Scientific” to notify the public that this issue has been classified as a Class I Recall.
Boston Scientific initiated the removal of certain Percutaneous Catheters from where they are used or sold. Affected devices:
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ENROUTE Transcarotid Neuroprotection System (NPS)
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ENROUTE Transcarotid Neuroprotection System Plus (NPS Plus)
These devices may be associated with Silk Road Medical within hospital inventory systems.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Boston Scientific at BSCFieldActionCenter@bsci.com or 1-763-415-7708.
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