Company: Medtronic, Inc.
Date of Enforcement Report 4/15/2009
Class:lll
PRODUCT
Medtronic RV Lead Integrity Alert, Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators, Recall # Z-1172-2009
REASON
Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R) Escudo” defibrillators. In those devices only, installation or removal of LIA will inadvertently turn off two audible patient alerts.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Mounds View, MN, by letters dated November 2008, and December 10, 2008.
VOLUME OF PRODUCT IN COMMERCE
55,755 units
DISTRIBUTION
Nationwide and Internationally
