Company:bioMerieux, Inc
Date of Enforcement Report:7/11/2007
Class:ll
PRODUCT
a) Vitatron C-Series dual chamber Rate Responsive Pacemakers (C60DR) includes the
following models: C60A1 and C60A3 for US distribution and C50A1, ..A2, A3, C60A2
for international distribution (the single chamber is not involved). C-series software is
VSF11/VSF12 Version 1.0. Recall # Z-0999-2007;
b) Vitatron T-Series Dual Chamber pacemaker T60 DR (model T60A1) for US distribution
(the single chamber is not involved) and the T70A1 for internationally distribution.
T-Series software VSF07/VSF08 Version 1.2, Recall Z-1000-2007
REASON
Pacing rate; Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient’s intrinsic rate falls below the programmed lower rate.
CODE
a) All lots/serial numbers; software VSF11/VSF12 Version 1.0;
b) All lots/serial numbers; software VSF07/VSF08 Version 1.2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Minneapolis, MN, by letters on February 12, 2007.
Manufacturer: Medtronic Swiss Manufacturing Facility, Tolochenaz, Switzerland. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
83,938 units
DISTRIBUTION
Nationwide
