Abiomed AB5000 Portable Driver Catalog number: 0025-0000 The AB5000 System is a mechanical circulatory support system fo

FDA device recall Z-1914-2009 · posted 2009-09-01 · Terminated

Recall details

Recalling firm

Abiomed, Inc.

Reason for recall

The Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition.

Action taken

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 switch the patient to hand pump support and switch patient to backup driver until they can confirm that the Driver(s) has been corrected by an Abiomed Field Service. Questions are to be directed to Michael O'Hara at 978-646-1543 or a Field Service at 800-554-8666.

Root cause

Finished device change control

Status

Terminated

Product code

DSQ

Quantity affected

18 units

Distribution

Worldwide Distribution -- USA, including states of AL, IN, FL, NJ, NY, and OH and countries of Germany, Greece, and Sweden.

Date initiated

2009-05-08

Date posted

2009-09-01

Date terminated

2012-01-26

Location

Danvers, MA