Medtronic recalls PVAC GOLD catheters (990078) produced in past 18 months without updated instructions to reduce phrenic nerve injury risk during heart procedures.
“Medtronic PVAC GOLD Catheter Recall: Phrenic Nerve Injury Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68915-medtronic-pvac-gold-catheter-recall-phrenic-nerve-injury-risk. Based on FDA recall #Z-1069-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1069-2019%22&limit=1).
The FDA announced on March 4, 2019, that Medtronic Inc. is recalling its Pulmonary Vein Ablation Catheter GOLD (PVAC GOLD) due to the potential for phrenic nerve injury. The firm issued updated instructions for use to address this hazard.
The recall addresses the potential for phrenic nerve injury associated with the device. The Pulmonary Vein Ablation Catheter GOLD is designed for creating endocardial lesions during cardiac ablation procedures for symptomatic Atrial Fibrillation.
Context
GovInfoNow's records show Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has had 29 other recalls since December 19, 2017. Recent brand recalls include implantable defibrillators with reduced energy output risks announced on May 10, 2023, and June 22, 2022, as well as a sterility risk in C304-HIS Devices reported on April 20, 2022. Other recent recalls of similar products include the Medtronic Sphere-9 Catheter Recall (March 11, 2026), Bard PowerPICC Catheters Recall (May 21, 2026), and Getinge Thoracic Catheter Recall (August 7, 2026).
How to tell if you have this one
Check for the model number 990078 on the catheter packaging. The recall affects all units distributed in the past 18 months without the updated instructions for use.
Brand
Medtronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Instructions for Use
Verify if your catheter has the updated instructions for use (IFU) as the outdated version could increase phrenic nerve injury risk.
How this recall unfolded
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1069-2019 (March 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1069-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.