Auris—Monarch Aspirating Biopsy Needles: May Break during Use

July 3, 2019 | Strategic Insights for Health System


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In a June 24, 2019, Urgent Medical Device Recall Removal letter submitted by an ECRI Institute member hospital, Auris states that it has received two new reports of the above needles breaking during use. Previously, Auris had sent out an April 19, 2019, Field Safety Notice with updated instructions for use (IFU) for the above products. If the above needles break, potential risks to patients include foreign body reactions, localized inflammatory reactions, delayed procedures, surgical intervention, and needle migration. Auris further states that it has received no reports of adverse events associated with this problem. The manufacturer has not confirmed the...

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