Z-0999-2007

Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C60A1 and...

Name: Z-0999-2007 Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C60A1 and...
Creator: Medtronic Inc. Cardiac Rhythm Managment
Published: 2007-02-05
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2007-02-05 / Terminated / root cause: software

FDA source

Medtronic Inc. Cardiac Rhythm Managment began a recall of 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... on 2007-02-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0999-2007
Status: Terminated
Initiated: 2007-02-05
Posted: 2007-07-07
Terminated: 2008-10-16
Recalling firm: Medtronic, Inc.
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 Arnhem, The Netherlands.
Product code: NVZ Pulse Generator, Permanent, Implantable
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 4,294
Distribution: within the US to include: AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, NC, ND, NJ, NY, OH, OK, SC, TX.
Product codes and lots: All lots/serial numbers

Product code NVZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)