Medtronic Pulmonary Vein Ablation Catheter Recalled for Phrenic Nerve Injury Risk
Medtronic is recalling PVAC GOLD catheters to reduce the potential for phrenic nerve injury during cardiac ablation procedures.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses a risk-of-harm product (phrenic nerve injury) where injury has not yet been reported, fitting the 'High' severity criteria for medical devices with potential for significant harm.
Plain-English summary
Medtronic Inc. is recalling the Pulmonary Vein Ablation Catheter GOLD (PVAC GOLD) 990078. The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
The recall affects 2,917 units distributed internationally in Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, and the United Kingdom. All lot numbers distributed in the past eighteen months and all newly manufactured units without the updated Instruction for Use (IFU) are affected until product with the updated IFU is available.
Healthcare providers should use the updated instructions for use to mitigate the risk of phrenic nerve injury during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation.
The recalled product
- 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…
- Hazard
- Affected units
- 2,917
Distribution
Distribution scope not specified by the agency.
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