Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Date of Enforcement Report: 7/15/2020
Class II
PRODUCT
CareLink SmartSync Device Manager, Model Number 24970A
Recall Number: Z-2505-2020
REASON
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.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on 6/4/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2773 devices
DISTRIBUTION
U.S. Nationwide and International