Medtronic Inc. Cardiac Rhythm Managment Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C60A1 and C60A3. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer) for permanent atrial and ventricular pacing. C-series software is VSF11/VSF12 Version 1.0. Vitatron is a division of Medtronic, Inc., Sales Office is Vitatron USA, 7000 Central Ave., NE, Minneapolis, MN 55423-3576. The head office is Vitatron B.V., P.O. Box 5227, 6802 EE Arnh Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C60A1 and C60A3. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer) for permanent atrial and ventricular pacing. C-series software is VSF11/VSF12 Version 1.0. Vitatron is a division of Medtronic, Inc., Sales Office is Vitatron USA, 7000 Central Ave., NE, Minneapolis, MN 55423-3576. The head office is Vitatron B.V., P.O. Box 5227, 6802 EE Arnh
Brand
Medtronic Inc. Cardiac Rhythm Managment
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Products Sold
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Medtronic Inc. Cardiac Rhythm Managment is recalling Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C due to Pacing rate; Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Advisory letters to physicians were mailed in February 2007. Sales respresentatives will follow-up with physicians by visit. A programmer software update will be released upon regulatory approval. The Advisory Letter provided short-term direction to reduce problems pending software upgrades.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CT, FL, GA, IL, IN, KY, MD, MA, MI, MN, NJ, NY, NC, ND, OH, OK, SC, TX
Page updated: Jan 10, 2026