Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to

Is my product affected?

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 (

• UPC 00643169522572

Check against the official notice below — it lists the full affected range.

What happened

Medtronic Inc. is addressing a potential safety concern with its Pulmonary Vein Ablation Catheter GOLD devices distributed internationally. The devices were designed for pulmonary vein ablation procedures but carried a potential risk of phrenic nerve injury. The company issued updated instructions for use to reduce this risk. Approximately 2,917 units with specific lot numbers distributed in the past eighteen months are affected, along with any newly manufactured units without the updated instructions.

The affected devices were distributed to Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, and the United Kingdom. The source document does not specify what remedy or action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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. Quantity: 2917 units 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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