Medtronic Pulmonary Vein Ablation Catheter(R) GOLD recall
Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be…
Why was Medtronic Pulmonary Vein Ablation Catheter(R) GOLD recalled?
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be…
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 2917 units
- 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.
- Recall date
- April 3, 2019
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)