FDA recall Z-2510-2020

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Class II · device

Product

Azure S SR MRI, Model Number W3SR01

Reason for recall

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.

Distribution

worldwide

Key facts

Status: Ongoing
Initiation date: 2020-06-04
Report date: 2020-07-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2510-2020