11

Jul

2007

Medtronic Inc. Class II

0

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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