Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2019 - (Recall #: Z-1069-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: March 4, 2019

Date Posted: April 3, 2019

Recall Number: Z-1069-2019

Event ID: 82319

Reason for Recall:

The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.

Status: Ongoing

Product Quantity: 2917 units

Code Information:

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.

Distribution Pattern:

International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated