AMS 700 MAUDE Updates — May 2026

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AMS 700 — May 2026 MAUDE Reported Device Age at Mechanical Malfunction

Summary Statistics

• N: 76/154 with documented dates
• Median: 3 years
• Mean: 4 years
• Max: 10 years

Percent Distribution

Code: Select all

≤1 yr     — 40%
1–4 yrs   — 18%
5–10 yrs  — 40%  (Similar to Titan)


Source: FDA MAUDE Database
Disclaimer: These are failure stats and not survival probability. Not professionally peer-reviewed and can have errors.

Summary of Events

1. INFECTION

1. Infection is a recurring reason for explant — commonly scrotal infections with purulence, swelling, redness, pain, and pus.
2. In many infection cases a temporary Tactra or malleable spacer was placed to preserve corporal space until the infection cleared.
3. Infection types included recurrent UTIs, incision-site infections, bacterial/Staphylococcus infections, and chronic urethral-mucosa infection causing extrusion; some required full washout with antibiotics.
4. Infection sometimes coexisted with other complications (e.g., a herniated and infected reservoir with inguinal abscess; post-implant pain later found to be scrotal infection). Classified as a known inherent risk per the IFU.

2. MALFUNCTION

1. Fluid loss/leakage was the most common malfunction — holes, tears, pinholes, and peeling cylinder coating.
2. Tubing failures — broken, kinked, cracked, or disconnected tubing, including a cluster of "crack in pump/cylinder connecting tube."
3. Pump failures — won't inflate/deflate, sticky or dimpled pumps, micropunctures, faulty lock-out valves, and failed activation testing.
4. Inflation/deflation problems — incomplete inflation, spontaneous/auto-deflation during intercourse, inflate-then-deflate; some no-leak cases were attributed to corporal stretch or scar capsule.
5. Cylinder structural failures — bulges, aneurysmal change, buckling, layer dissociation, and fabric ingrowth.
6. Lab analyses found wear at folds and kink-resistant tubing worn to filament; many holes were attributed to sharp-instrument damage during explant rather than a manufacturing defect.
7. Reservoir malfunctions — empty reservoirs, tubing holes, and need for refill.

3. MALPOSITION

1. Reservoir herniation — reservoir migrated out of the space of Retzius into the scrotum, groin, inguinal area, bladder, or ureter, causing pain.
2. Pump migration — pump rotated, pulled up, or positioned too low or too deep posteriorly.
3. Gland hypermobility ("floppy glans") — only the glans engorges while the shaft stays flaccid; some loss of glans sensation reported.
4. Erosion / impending erosion — cylinders or pump eroding through the urethra or scrotum, including urethral extrusion.
5. Crossover — distal or proximal crossover; sometimes attributed to original surgical misplacement (unintended use error).
6. Cylinder migration — e.g., right cylinder migrating into the scrotum; cylinders folding over.
7. Aneurysms — cylinder aneurysmal change (often left-sided) with bulging and loss of axial rigidity; some required planned corpora cavernosa reconstruction.

4. PATIENT DISSATISFACTION

1. Size & rigidity — device too long/too large, sizing/measurement errors of roughly 3–4 cm, inadequate rigidity, Tenacio pump perceived as "too hard" or not fully inflating, and erections not staying stiff; often resolved by swapping a Tenacio pump for an MS pump.
2. Cosmetic / placement concerns — pump placement or discomfort too low, reservoir bulge, cylinder herniation with dissatisfaction, and difficulty pumping/inflating.