AMS 700 Reported Mechanical Malfunctions - January 2026 Updates from MAUDE DB

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AMS 700 Reported Mechanical Malfunctions - January 2026 Updates from MAUDE DB

102 Mechanical Events out of 161 Adverse Events (63% are purely mechanical)

Survival Until a Mechanical Malfunction:
Max - 14 years
Mean - 4 years
Median - 4 years

<= 1 year 35%
2-5 years 26%
6-10 years 35%
11-15 years 3%
16-20 years 0%


https://www.fda.gov/medical-devices/med ... data-files