FDA Medical Device Recalls (openFDA)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): 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.
- Recall number
- Z-1069-2019
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- 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.
- Status
- Open, Classified
- Initiated
- 2019-03-04
- Posted
- not on file
- Terminated
- not on file
- Reason
- The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OAE
- Firm FEI
- 2182208
- Firm city
- Mounds View
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28