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.
- Recall Initiated
- March 4, 2019
- Recall Number
- Z-1069-2019
- Quantity
- 2917 units
- Firm Location
- Mounds View, MN
Reason for Recall
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
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.
Root Cause
Labeling Change Control
Action Taken
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.