Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AB5000 Portable Driver

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall AB5000 Portable Driver see related information
Date Initiated by Firm May 08, 2009
Date Posted September 01, 2009
Recall Status1 Terminated 3 on January 26, 2012
Recall Number Z-1914-2009
Recall Event ID 52168
PMA Number PMA-P900023 
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 MA 01923
For Additional Information Contact
978-777-5410 Ext. 225
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-