Edwards—ThruPort Systems ​Knot Pushers and Valve Placement Packs: Knot Pusher Slot Configuration May Cause Suture to Fray or Split

September 16, 2015 | Risk Management News

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ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In an August 26, 2015, Urgent Product Recall Action Required letter submitted by an ECRI Institute member hospital, Edwards states that the configuration of the slot at the tip of the knot pushers below may inhibit ease of use and cause the suture to fray or split, which could compromise the integrity of the suture knot. The manufacturer has not confirmed the...

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