Recall – CRT therapy manager sequence may result in suspension of therapy

Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Date of Enforcement Report: 7/15/2020
Class II


CareLink SmartSync Device Manager, Model Number 24970A

Recall Number: Z-2505-2020


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.


Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on 6/4/2020. Voluntary:  Firm Initiated recall is ongoing.


2773 devices


U.S. Nationwide and International

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