Spectra 720054-03Recalls & reported problems
American Medical Systems, Inc. · Concealable Penile Prosthesis, 2 Cylinders · Class 2 · Implant
All models of Spectra (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878953005225), received between Jan 19, 2018 and Feb 7, 2020 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information1
- Migration1
Patient problems
- Perforation2
- Erosion1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2020Migration; Migration
IT WAS REPORTED THAT THE PATIENT'S SPECTRA PENILE PROSTHESIS WAS EXTRUDING ON THE LEFT SIDE THROUGH THE URETHRA, WITH NO EVIDENCE OF LOCAL INFECTION.
Patient problems: Erosion; Perforation
MAUDE report 9680642 ↗InjuryJan 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT WAS NOT HAPPY WITH THEIR SPECTRA PENILE PROSTHESIS. THE PATIENT HAD PREVIOUSLY HAD AN INFLATABLE PENILE PROSTHESIS. THE SPECTRA PENILE PROSTHESIS WAS PLACED AS A SPACE SAVER. THE DEVICE WAS REPLACED WITH A 100 ML RESERVOIR, PUMP, AND 18 CM X 12 MM CYLINDERS. PRODUCT WAS EXPLANTED BUT NOT EXPECTED TO BE RETURNED. SHOULD ADDITIONAL INFORMATION BE RECEIVED OR PRODUCT BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF PRODUCT ANALYSIS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8273272 ↗InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS REMOVED AND REPLACED DUE TO INFECTION OF THE SURGICAL SITE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 7559778 ↗InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS REMOVED AND REPLACED DUE TO PERFORATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: Perforation
MAUDE report 7207882 ↗
Other Prosthesis, Penile devices
- TACTRA 720081-01Boston Scientific Corporation · PROSTHESIS, PENILE150 reports
- Spectra 720074-02American Medical Systems, Inc. · Prosthesis, Penile97 reports
- Genesis 91-9511SCColoplast A/S · PROSTHESIS, PENILE85 reports
- TACTRA 720080-01Boston Scientific Corporation · PROSTHESIS, PENILE61 reports
- Genesis 91-9509SCColoplast A/S · PROSTHESIS, PENILE49 reports
- TACTRA 720082-01Boston Scientific Corporation · PROSTHESIS, PENILE49 reports
- Spectra 720074-03American Medical Systems, Inc. · Prosthesis, Penile47 reports
- Spectra 720054-02American Medical Systems, Inc. · Prosthesis, Penile44 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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