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All product recalls associated with Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF).
Total Recalls
156
Past Year
0
Class I (Serious)
0
Most Recent
May 2023
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
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.