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U.S. Department of Health and Human Services

Class 2 Device Recall AB5000 Portable Driver

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 Class 2 Recall
AB5000 Portable Driver
see related information
Date Posted September 01, 2009
Recall Status1 Open
Recall Number Z-1914-2009
Recall Event ID 52168
Premarket Approval
PMA Number
P090002
Product Classification Ventricular (Assisst) Bypass - Product Code DSQ
Product 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.
Code Information Serial numbers: AF0013 - AF0015, AF0017, AF0018, AF0020, AF0022-AF0024, AF0028, AF0030, AF0037, AF0038, AF0043, AF0049, and AF0053 - AF0055.
Recalling Firm/
Manufacturer
Abiomed, Inc.
22 Cherry Hill Dr
Danvers, Massachusetts 01923
Manufacturer Reason
for Recall
The Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 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.
Quantity in Commerce 18 units
Distribution Worldwide Distribution -- USA, including states of AL, IN, FL, NJ, NY, and OH and countries of Germany, Greece, and Sweden.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = DSQ and Applicant = DEPUY ORTHOPAEDICS, INC.
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