Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall
MedSun: Newsletter #60, May 2011

FDA MedWatch Safety Alert

The deployment tube may detach during use due to insufficient adhesive and may result in the failure of the product to operate. This may cause serious injury and/or death. Customers were instructed to immediately examine their stocks for the affected product and discontinue distributing the affected lot.

Additional Information:

FDA MedWatch Safety Alert. Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall. April 1, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm249395.htm


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