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Terminated

BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000

FDA Recall Z-1222-03 · Posted 2003-09-11

Recalling FirmAbiomed, Inc.
Recall StatusTerminated
Product CodeDSQ
Date Initiated2003-08-19
Date Terminated2003-10-15
Product Quantity36

Reason for Recall

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

Firm Action

Abiomed notified customers by letter on 8/19/03 advising users of the problem and requesting that the unit not be used until a field service representative corrected the device.

Root Cause

Other

Distribution Pattern

Nationwide. CA, DE, IL, IN, KY, FL, LA, MD, ND, NJ, NY, OR, WI, TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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