Z-1069-2019Class III

Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 -

Name: Z-1069-2019 Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 -
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2019-03-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-03-04 / Open, Classified / root cause: labeling and UDI

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of 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... on 2019-03-04. FDA classified it as Class III and gives the reason as "The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1069-2019
Classification: Class III
Status: Open, Classified
Initiated: 2019-03-04
Posted: 2019-03-28
Recalling firm: Medtronic, Inc.
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.
Product code: OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Reason for recall: The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The firm initiated the communication on 03/04/2019 by letter. Consignees are asked to review the communication to understand that Medtronic is adding current recommendations for reducing the potential for PNI. The IFU will be updated globally, including completing submissions and obtaining regulatory approvals, where prior approvals are required. This event involves OUS consignees only.
Quantity in commerce: 2917 units
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1069-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1069-2019	Class III	Ongoing	Voluntary: Firm initiated	2019-04-03	2019-03-28

Product code OAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)