Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01

Recall date

June 4, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2507-2020

FDA classification

Class II

Brand / firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Sold / distributed

worldwide

Why it was recalled

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01