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Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall - Insufficient Adhesive
AUDIENCE: Risk Manager, Cardiology, Surgery
ISSUE: 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.
BACKGROUND: This device is used by cardiac surgeons during coronary artery bypass procedures (CABG). It helps to control the flow of blood in the aorta during surgery. This allows the surgeon to create an important connection between blood vessels (proximal anastomosis) without the use of an aortic clamp. Customers were notified on May 5, 2010 of the device recall by Maquet Getinge Group.
RECOMMENDATION: Customers were instructed to immediately examine their stocks for the affected product and discontinue distributing the affected lot. For Product Lot numbers affected please refer to the Recall Notice.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Class I Recall Notice, at:
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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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