Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
FDA Recall Z-0940-2011 · Posted 2011-02-01
Recalling FirmMaquet Cardiovascular, LLC
Recall StatusTerminated
Product CodeDXC
Date Initiated2010-05-05
Date Terminated2011-06-21
Product Quantity1630
Reason for Recall
Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.
Firm Action
The firm, MAQUET Getinge Group, sent an "URGENT DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated May 5, 2010, to all customers via Federal Express. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to immediately examine their stocks to determine if they have any of the affected product, if found, discontinue dispensing (distributing) the lot and complete the Field Action Response Form; immediately contact accounts if they acted as a distributor, and acknowledge receipt of this notification whether or not they have any affected products by completing the Field Action Response Form via fax to (U.S.): 1-888-899-2874.
If you have any additional questions, please contact your local MAQUET Cardiovascular sales representative or our Customer Service at 1-888-880-2874.
Root Cause
Process design
Distribution Pattern
Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.