medical Class III Updated 2019-04-03

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOL

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom.
Lot/Code Info: UDI 00643169522572 All lot numbers distributed in the past eighteen (18) months and all newly manufactured without the updated IFU are affected until product with the updated Instruction for Use (IFU) is available.
View official government recall

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