Genesis and Tactra MAUDE Updates - May 2026

[lasthope2.0]

Summary of Reported Adverse Events

GENESIS (Coloplast) — 5 events

1. Patient dissatisfaction (size) was the leading issue — 2 of 5 events were incorrect sizing, including one patient switching from 9.5 mm to 11 mm.
2. One malfunction — a cylinder break after 3 years of use led to removal and replacement with a Titan.
3. One malposition — device placed incorrectly, removed and replaced with a Titan.
4. One explant with no documented reason — revision performed but cause not recorded (unspecified).
5. Zero infections reported, and no device was returned to Coloplast for evaluation in any case.

TACTRA (Boston Scientific) — 11 events

1. Malposition was the leading clinical complication — 3 events: one left distal erosion (explant + grafting) and two curvature/curve-correction cases.
2. Two infections — one in the corpora cavernosa (diagnosed intraoperatively) and one penoscrotal infection linked to heavy lifting before the incision had healed; both devices explanted and replaced.
3. Two patient-dissatisfaction events — instability/short-lasting erection (replaced with a 2 cm longer device) and difficulty during intercourse (replaced with an IPP).
4. Four explants/replacements with no stated reason — the largest single group; one was replaced with an IPP.
5. No pure malfunctions reported, and product details were frequently missing, limiting Boston Scientific's ability to investigate.