CLASS III ONGOING Device recall · Reported 3 Apr 2019 · FDA Enforcement Report
Medtronic Pulmonary Vein Ablation Catheter(R) Gold recalled
Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf) is recalling Medtronic Pulmonary Vein Ablation Catheter(R) Gold (Pvac Gold) 990078. The recall was initiated on 4 Mar 2019 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1069-2019
- FDA event ID
- 82319
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf), Mounds View, MN
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 4 Mar 2019
- FDA classified
- 28 Mar 2019
- Reported
- 3 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 4 Mar 2019 | Recall initiated by company | |
| 28 Mar 2019 | Classified by FDA | +24 days |
| 3 Apr 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Product as listed by the FDA
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.
Where it was distributed
International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom.
Questions about this recall
Why was it recalled?
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Which lots are affected?
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.
Where was it sold?
International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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