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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Cathe
Recalled April 3, 2019 · FDA recall Z-1069-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury. · FDA Class III
Units
2917 units
Sold at
International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom.
Description
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
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.
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →