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 Cath…

Recall date

March 4, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1069-2019

FDA classification

Class III

Brand / firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Sold / distributed

International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom.

Why it was recalled

The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.