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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Reason for Recall:
- The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1069-2019
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