Recall Z-0940-2011 ยท DXC Clamp, Vascular
Maquet Cardiovascular, LLC
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.
| Date | Feb 1, 2011 (initiated May 5, 2010) |
| Status | Terminated |
| Reason | Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate. |
| Root cause | Process design |
| 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 affe |
| Quantity | 1630 |
| Distribution | Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022880 | GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 Guidant Corp., Sep 13, 2002 |