Recall Z-1914-2009 ยท DSQ Ventricular (Assist) Bypass
Abiomed, Inc.
Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used to facilitate patient transport . The Driver is external to the patient and is intended for short-term use.
| Date | Sep 1, 2009 (initiated May 8, 2009) |
| Status | Terminated |
| Reason | The Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition. |
| Root cause | Finished device change control |
| Action | Abiomed notified customers via an Urgent - Voluntary Medical Device Field Removal Notice on May 8, 2009 advising users that the Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition. The letter stated that customers may continue to support patients with the AB Portable Driver during the process since the failure has not occurred during patient support. An Abiomed Field Service Engineer will contact customers and arrange for a temporary exchange for the affected driver with a corrected driver. The firm recommends that customers sw |
| Quantity | 18 units |
| Distribution | Worldwide Distribution -- USA, including states of AL, IN, FL, NJ, NY, and OH and countries of Germany, Greece, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.