Z-1069-2019 Class III Ongoing
FDA device recall Z-1069-2019 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on March 4, 2019 and is designated Class III. Reason for recall: The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury. The recall status is ongoing. Affected quantity: 2917 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- March 4, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2917 units
Product 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.
Reason for Recall
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Distribution Pattern
International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom.
Code Information
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.