FDA Device recall Z-1069-2019
Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designe…
- FDA Device
- Class III
- ongoing
- Published 2019-04-03
On 2019-04-03 the FDA classified a Class III recall of Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designe… by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing the firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1069-2019 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2019-03-04 |
| Published | 2019-04-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | n/a |
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 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
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Identifiers
| code_info | UDI 00643169522572 All lot numbers distributed in the past eighteen (18) months and all newly manufactured without t…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1069-2019%22
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