FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1914-2009
- Recalling firm
- Abiomed, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2009-05-08
- Posted
- 2009-09-01
- Terminated
- 2012-01-26
- 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 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
- 18 units
- Distribution
- Worldwide Distribution -- USA, including states of AL, IN, FL, NJ, NY, and OH and countries of Germany, Greece, and Sweden.
- Lot, serial or model codes
- Serial numbers: AF0013 - AF0015, AF0017, AF0018, AF0020, AF0022-AF0024, AF0028, AF0030, AF0037, AF0038, AF0043, AF0049, and AF0053 - AF0055.
- 510(k) numbers
- not on file
- PMA numbers
- ["PMA-P900023"]
- Product code
- DSQ
- Firm FEI
- 1220648
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28