Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ Intended use: medi
FDA device recall Z-0940-2011 · posted 2011-02-01 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- Reason for recall
- Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.
- Action taken
- 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
- Status
- Terminated
- Product code
- DXC
- Quantity affected
- 1630
- Distribution
- Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel
- Date initiated
- 2010-05-05
- Date posted
- 2011-02-01
- Date terminated
- 2011-06-21
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 (K022880) | Guidant Corp. | 2002-09-13 |