Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive Pacemaker includes the following models: C60A1 and C60A3. The
FDA device recall Z-0999-2007 · posted 2007-07-07 · Terminated
Recall details
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Managment
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NVZ
- Quantity affected
- 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.
- Date initiated
- 2007-02-05
- Date posted
- 2007-07-07
- Date terminated
- 2008-10-16
- Location
- Minneapolis, MN
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