Recall Z-0824-2010 ยท DSQ Ventricular (Assist) Bypass
Abiomed, Inc.
Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.
| Date | Mar 4, 2010 (initiated Dec 16, 2009) |
| Status | Terminated |
| Reason | Console shut down with no audible alarm |
| Root cause | Process control |
| Action | Abiomed initiated the recall by telephone contact and followed with a Recall Letter dated January 27, 2010. Consignees were informed that a Field Service Engineer will be in contact and schedule a time to visit and correct the affected device. For further information, contact Abiomed Quality Assurance at 1-978-656-1543 or Abiomed Field Service at 1-800-554-8666. |
| Quantity | 496 units |
| Distribution | Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.