Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01

Hazard / Issue

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.

Issued by

FDA

Distribution: worldwide

Lot/Code Info: a) W1SR01, serial numbers: RNA200005H RNA200007H RNA200011H RNA200013H RNA200016H RNA200017H RNA200020H RNA200021H RNA200022H RNA200024H RNA200025H RNA200026H RNA200028H RNA200029H RNA200089H RNA200090H RNA200091H RNA200092H RNA200093H RNA200094H RNA200095H RNA200096H RNA200098H RNA200100H RNA200102H RNA200103H RNA200104H RNA200105H RNA200106H RNA200107H RNA200108H RNA200109H RNA200110H RNA200111H RNA200112H RNA200113H RNA200114H RNA200115H RNA200116H RNA200118H RNA200119H RNA200120H RNA200121H RNA200122H RNA200123H RNA200125H RNA200126H RNA200127H RNA200128H RNA200130H RNA200131H RNA200132H RNA200133H RNA200134H RNA200135H RNA200136H RNA200139H RNA200140H RNA200141H RNA200142H RNA200144H RNA200145H RNA200146H RNA200147H RNA200148H RNA200149H RNA200150H RNA200151H RNA200152H RNA200154H RNA200155H RNA200157H RNA200158H RNA200160H RNA200161H RNA200162H RNA200163H RNA200164H RNA200165H RNA200169H RNA200170H RNA200171H RNA200172H RNA200173H RNA200174H RNA200176H RNA200177H 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