Medtronic Pulmonary Vein Ablation Catheter — Class III medical device recall Z-1069-2019
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2019-04-03. The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
| Recall number | Z-1069-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2019-03-04 |
| Classified | 2019-03-28 |
| Reported by FDA | 2019-04-03 |
| Countries outside the US | AT, AU, BR, CA, CH, DE, ES, FR, GB, HU, IE, IL, IT, LV, NL, PL, PT |
| Quantity | 2,917 units |
| UPC / GTIN / UDI-DI | 00643169522572 |
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 for recall
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1069-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.