—#171345

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.

FDA product code: OAE — Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Device class: Class 3
Medical specialty: Unknown
Affected 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.

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

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.

Timeline

Recall initiated: 2019-03-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171345. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.