Recall Z-1069-2019— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class III · Ongoing
Class III FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2019-03-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD is also intended to be used for cardiac electrophysiological (EP) mapping of pulmonary vein potentials, delivery of diagnostic pacing stimuli and verifying electrical isolation of the pulmonary veins post-treatment.. Reason: The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2019-03-04
- Firm location
- Mounds View, MN, United States
Product description
Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD is also intended to be used for cardiac electrophysiological (EP) mapping of pulmonary vein potentials, delivery of diagnostic pacing stimuli and verifying electrical isolation of the pulmonary veins post-treatment.
Reason for recall
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.