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Open, Classified

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.

FDA Recall Z-1069-2019 · Posted None

Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Recall StatusOpen, Classified
Product CodeOAE
Date Initiated2019-03-04
Product Quantity2917 units

Reason for Recall

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

Firm Action

The firm initiated the communication on 03/04/2019 by letter. Consignees are asked to review the communication to understand that Medtronic is adding current recommendations for reducing the potential for PNI. The IFU will be updated globally, including completing submissions and obtaining regulatory approvals, where prior approvals are required. This event involves OUS consignees only.

Root Cause

Labeling Change Control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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