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Abiomed BVS 5000 Bi-Ventricular Support System

by Abiomed Cardiovascular, Inc.

PMA P900023

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 20 Nov 1992

PMA

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP900023 Date20 Nov 1992Approval withdrawnStatusWithdrawn

Recalls

3 recalls · FDA

    • Terminated Z-0824-2010 FDA Unclassified (pre-2012) initiated 16 Dec 2009

    Console shut down with no audible alarm

    • Terminated Z-1931-2009 FDA Unclassified (pre-2012) initiated 23 Apr 2009

    iPulse Console SC1035 displayed a "Low Pressure / Low Flow" alarm and stopped pumping during patient transport in battery operation.

    • Terminated Z-1222-03 FDA Unclassified (pre-2012) initiated 19 Aug 2003

    Bi-Ventricular support system may switch to battery when primary voltage (AC) is available

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Full name
Abiomed Bvs 5000 Bi-Ventricular Suppport System
Trade Name
Abiomed Bvs(R) 5000 Bi-Ventricular Support System
Generic Name
Ventricular (assist) bypass
PMA Number
FDA Product Code
DSQ
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APWD Approval withdrawn