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All product recalls associated with ela Medical Llc.
Total Recalls
8
Past Year
0
Class I (Serious)
0
Most Recent
Sep 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.
Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew.
Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process.
Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process.