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All product recalls associated with St Jude Medical CRMD.
Total Recalls
10
Past Year
0
Class I (Serious)
0
Most Recent
Jan 2008
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.
A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an arrhythmia. If an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
Device Separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.
St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status.