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

[lasthope2.0]

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

[Thisworld]

Thanks

[Kodixx]

lasthope2.0, thanks also for sending this out. As with the Titan report, the number of failures seems really small given that hundreds of thousands of these are implanted over 10-20 years.

- Chuck

AMS 700 Reported Mechanical Malfunctions - January 2026 Updates from MAUDE DB
102 Mechanical Events out of 161 Adverse Events (63% are purely mechanical)

[Rodsmen]

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

Thank you so much for posting this. I have not yet succeeded in using the MAUDE DB. Is there a way to look for AMS 700CX cylinder failure reports?

[lasthope2.0]

lasthope2.0, thanks also for sending this out. As with the Titan report, the number of failures seems really small given that hundreds of thousands of these are implanted over 10-20 years.

- Chuck

AMS 700 Reported Mechanical Malfunctions - January 2026 Updates from MAUDE DB
102 Mechanical Events out of 161 Adverse Events (63% are purely mechanical)

I agree, Chuck, well stated. As always, I love your optimism. This is indeed a tiny number out of the 60,000 annual surgeries performed globally, with 30,000 in the US alone. These reports (though imperfect, delayed and under-reported) come in from all over the world.

[lasthope2.0]

Thank you so much for posting this. I have not yet succeeded in using the MAUDE DB. Is there a way to look for AMS 700CX cylinder failure reports?

You're welcome, Rodsmen!
Many reports just mention "AMS INFLATABLE PENILE PROSTHESIS" with no details on the model. The best we can do is to look for the word "cylinder" and understand the failure modes. It will include all models, though.

[Rodsmen]

Thank you so much for posting this. I have not yet succeeded in using the MAUDE DB. Is there a way to look for AMS 700CX cylinder failure reports?

You're welcome, Rodsmen!
Many reports just mention "AMS INFLATABLE PENILE PROSTHESIS" with no details on the model. The best we can do is to look for the word "cylinder" and understand the failure modes. It will include all models, though.

That would be immensely helpful. I now their expandable model is a bit of an outlier, but I suspect the difference in the layered cylinder vs. the Coloplast is bigger than the difference between an AMS CX and others.