Spectra 720056-01Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878953005232), received between Apr 23, 2024 and Apr 23, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
- Purulent Discharge1
- Unspecified Heart Problem1
- Unspecified Infection1
- Unspecified Kidney or Urinary Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THIS MALLEABLE PENILE PROSTHESIS DUE TO INFECTION. IT WAS NOTED THE DEVICE WAS IMPLANTED AT THE TIME OF REMOVAL OF THE PREVIOUS DEVICE FOR INFECTION. THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY A WEEK. DESPITE TREATMENT WITH ANTIBIOTICS, THE INFECTION PERSISTED FOR ONE MONTH UNTIL IT WAS RESOLVED. NO NEW DEVICE WAS IMPLANTED FOLLOWING REMOVAL OF THE MALLEABLE PROSTHESIS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Purulent Discharge; Unspecified Heart Problem; Unspecified Infection; Unspecified Kidney or Urinary Problem
MAUDE report 19169487 ↗
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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