Prosthesis, Penile
Gastroenterology, Urology · 21 CFR 876.3630
Recent MDR events
2,754 adverse event reports on file
- TACTRAJul 20, 2026InjuryBoston Scientific Corporation2124215-2026-38830
- TACTRA MALLEABLE PENILE PROTHESISJul 14, 2026InjuryBoston Scientific Corporation2124215-2026-37709
- TACTRA MALLEABLE PENILE PROTHESISJul 14, 2026InjuryBoston Scientific Corporation2124215-2026-37887
- TACTRAJul 10, 2026InjuryBoston Scientific Corporation2124215-2026-37127
- TACTRA MALLEABLE PENILE PROTHESISJul 10, 2026InjuryBoston Scientific Corporation2124215-2026-37231
- TACTRAJul 9, 2026InjuryBoston Scientific Corporation2124215-2026-36962
- TACTRAJul 9, 2026InjuryBoston Scientific Corporation2124215-2026-36981
- TACTRAJul 7, 2026InjuryBoston Scientific Corporation2124215-2026-36267
- TACTRA MALLEABLE PENILE PROTHESISJul 6, 2026InjuryBoston Scientific Corporation2124215-2026-36106
- TACTRA MALLEABLE PENILE PROTHESISJul 6, 2026InjuryBoston Scientific Corporation2124215-2026-36121
Event type breakdown
Recalls
3 recall events for this product code
- Coloplast Manufacturing US, LLCTerminatedApr 27, 2015
Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250.
Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is printed directly on the individual prosthesis tray during the packaging process and states the correct size, 9.5 mm.
Z-1538-2015 · View FDA record ↗ - American Medical SystemsTerminatedApr 3, 2007
AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN
Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
Z-0702-2007 · View FDA record ↗ - American Medical SystemsTerminatedApr 3, 2007
AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN
Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
Z-0703-2007 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
Boston Scientific Limited
CLONMEL Tipperary, IE
Rigicon As
Bakirkoy Istanbul, TR
Isomedix Operations, Inc.
Minneapolis, MN, US
Boston Scientific Limited
GALWAY, IE
Boston Scientific Corporation
Saint Paul, MN, US
Rigicon, Inc.
Ronkonkoma, NY, US
Boston Scientific Corporation
Marlborough, MA, US
Boston Scientific Corporation
Coventry, RI, US
Coloplast Manufacturing Us, Llc
MINNEAPOLIS, MN, US
Synergy Health Ast, Srl
Alajuela, CR
510(k) clearances
32 clearances for this product code
- Boston Scientific CorporationApr 16, 2019
K183619 · Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
- Rigicon, Inc.Apr 15, 2019
K181673 · Rigi10 Malleable Penile Prosthesis
- American Medical Systems, Inc.Apr 9, 2009
K090663 · AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- American Medical Systems, Inc.Oct 20, 2008
K082006 · AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
- Mentor Corp.Oct 29, 2004
K040959 · MENTOR GENESIS PENILE PROSTHESIS
- American Medical Systems, Inc.Dec 4, 1996
K963328 · AMS AMBICOR PENILE PROSTHESIS
- Dacomed Corp.Oct 27, 1995
K953640 · DUNA II PENILE PROSTHESIS
- American Medical Systems, Inc.Jul 6, 1995
K951716 · AMS 650 MALLERABLE PENIEL PROSTHESIS