Biosense Webster—LASSO NAV Duo-Loop eco Catheters: May Be Difficult to Retract from the Patient

March 11, 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 a February 24, 2015, Urgent Voluntary Medical Device Recall Removal letter submitted by an ECRI Institute member hospital, Biosense Webster states that it has received reports of users experiencing difficulty retracting the below-listed mapping catheters from patients, potentially leading to damage of the catheter's spine cover and exposure of the inner catheter components. Biosense Webster also states that there is no risk to patients who have been successfully mapped using the catheters. The manufacturer has not confirmed the...

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