—#94744

Product

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 product code: DXC — Clamp, Vascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022880
Affected lot / code info: Lot numbers 12895788, 12946718, 25002866, 25004647, 13029141, 25005045, 25005622

Why it was recalled

Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel

Timeline

Recall initiated: 2010-05-05
Posted by FDA: 2011-02-01
Terminated: 2011-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94744. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.