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.
Recall
- Recall Number
- Z-0940-2011
- Event Number
- 56868
- Firm
- Maquet Cardiovascular, LLC
- FEI Number
- 2242352
- Product Code
- DXC
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- May 5, 2010
- Posted
- February 1, 2011
- Terminated
- June 21, 2011
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094
Description
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.
Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.
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.
Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel
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