SpectraRecalls & reported problems across all models

We found 9 models of Spectra by American Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 270 adverse event reports in the FDA's MAUDE database, received between Aug 29, 2017 and Jun 29, 2026 — classified as 241 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (87 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Spectra problems

Spectra models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Spectra 720074-02

  Prosthesis, Penile
  97 reports
• Spectra 720074-03

  Prosthesis, Penile
  47 reports
• Spectra 720054-02

  Prosthesis, Penile
  44 reports
• Spectra 720056-03

  Prosthesis, Penile
  25 reports
• Spectra 720074-01

  Prosthesis, Penile
  22 reports
• Spectra 720054-01

  Prosthesis, Penile
  19 reports
• Spectra 720056-02

  Prosthesis, Penile
  11 reports
• Spectra 720054-03

  Prosthesis, Penile
  4 reports
• Spectra 720056-01

  Prosthesis, Penile
  1 report

Recent Spectra adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP) EXPERIENCED EROSION ON RIGHT DISTAL CORPORAL BODY. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Scar Tissue; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 25661392 ↗
• InjuryMar 13, 2026Fracture; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS SPECTRA PENILE PROSTHESIS PRESENTED WITH DIFFICULTY WITH PENETRATION, PAIN, A LACK OF FIRMNESS IN THE PENIS, AND BENDS IN THE PENIS. PHYSICAL EXAMINATION OF THE PATIENT REVEALED THERE WERE SIGNS OF A FRACTURE IN THE DISTAL THIRD OF THE LEFT ROD, CREPITUS, AND LACK OF SUPPORT ACCOMPANIED BY LATERAL TORSION. A REVISION SURGERY HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Deformity/ Disfigurement; Pain

  MAUDE report 24596360 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS SPECTRA CONCEALABLE PENILE PROSTHESIS EXPERIENCED AN INFECTION AND EROSION WHICH LED TO EVALUATION AND DIAGNOSIS IN THE EMERGENCY ROOM. DURING REVISION SURGERY, THE DEVICE WAS EXPLANTED AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 24422095 ↗
• InjuryDec 16, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS SPECTRA WAS DISSATISFIED WITH THE DEVICE AND WAS EXPERIENCING PAIN. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 23816191 ↗
• MalfunctionNov 17, 2025Mechanical Problem; Mechanical Problem

  T WAS REPORTED THAT THIS SPECTRA PENILE PROSTHESIS (SPP) WAS NOT PERFORMING AS EXPECTED DUE TO MECHANICAL FAILURE. THE DEVICE EXHIBITED COMPLETE BENDING OF THE CYLINDERS, INABILITY TO MAINTAIN RIGIDITY DURING INTERCOURSE, AND AUDIBLE CLICKING SOUNDS UPON MANIPULATION, CONSISTENT WITH INTERNAL STRUCTURAL DAMAGE. THE SPP REMAINS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576773 ↗
• InjurySep 26, 2025Mechanical Problem; Nonstandard Device; Defective Device; Mechanical Problem; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS SPECTRA MALLEABLE PENILE PROSTHESIS WAS DISSATISFIED WITH THE DEVICE, STATING THAT IT WAS BENDING TOO EASILY. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE SPECTRA WAS REMOVED AND REPLACED WITH A TACTRA MALLEABLE PENILE PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23155761 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH A SPECTRA PENILE PROSTHESIS (SPP) EXPERIENCED AN INFECTION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE SPP AND REPLACE IT WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 22078602 ↗
• InjuryJan 10, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS SPECTRA PENILE PROSTHESIS (SPP) BECAME SOFT, THERE WAS NO POSSIBILITY OF PENETRATION, IT KEPT FOLDING AND BECAME SOFT. THE SPP WAS EXPLANTED AND REPLACED WITH A TACTRA DEVICE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124163 ↗
• InjuryDec 5, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT, ENROLLED IN THE IT MATTERS CLINICAL STUDY, WITH THIS SPECTRA PENILE PROSTHESIS (SPP), PRESENTED WITH THE DEVICE UNDERSIZED; THEREFORE, A REPLACEMENT SURGERY WAS SCHEDULED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856965 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ENROLLED IN THE IT MATTERS STUDY ON (B)(6) 2024 AND HAD A SPECTRA PENILE PROSTHESIS (SPP) IMPLANTED ON (B)(6) 2024. THE PATIENT DEVELOPED SCROTAL CELLULITIS 28 DAYS FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT REQUIRED HOSPITALIZATION AND ANTIBIOTICS TO MANAGE THE CONDITION FOR FOUR DAYS. THERE WERE NO DEVICE ISSUES NOTED. THE PATIENT HAS A FOLLOW UP APPOINTMENT SCHEDULED FOR EVALUATION. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS. ADDITIONAL INFORMATION REPORTED THAT AT THE PATIENT'S SIX MONTH FOLLOW UP, HE WAS USING HIS PROSTHESIS LESS OFTEN THAN DESIRED. THE PATIENT STATED HE HAS A LOSS OF SENSATION DUE TO PRIOR COMPLICATIONS WITH OTHER DEVICES AND PROCEDURES. HE ALSO HAS A HISTORY OF STROKE.

  Patient problems: Cellulitis; Erythema; Hematoma; Pain; Seroma; Swelling/ Edema; Unspecified Infection

  MAUDE report 20709344 ↗
• InjuryOct 17, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT, ENROLLED IN THE IT MATTERS CLINICAL STUDY, WITH THIS SPECTRA PENILE PROSTHESIS (SPP) HAS BEEN EXPERIENCING AN INTERMITTENT COLD SENSATION IN THE PENIS SINCE THE IMPLANT PROCEDURE. IN ADDITION, THE PATIENT STATED THAT HE FEELS THE DEVICE WAS UNDERSIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Deformity/ Disfigurement; Insufficient Information; Nerve Damage

  MAUDE report 20471482 ↗
• InjuryOct 9, 2024Mechanical Problem; Inadequacy of Device Shape and/or Size; Defective Device; Mechanical Problem; Inadequacy of Device Shape and/or Size; Defective Device

  IT WAS REPORTED THAT THE PATIENT, ENROLLED IN IT MATTERS CLINICAL STUDY WITH THIS SPECTRA PENILE PROSTHESIS, SUSPECTS THAT THEIR PENIS IS SHORTER THAN IT WAS PRIOR TO IMPLANT SIX MONTHS AGO. THE PATIENT IS UNABLE TO USE THE DEVICE AS OFTEN AS THEY LIKED. THE PHYSICIAN BELIEVED THAT THERE ARE NO DEVICE ISSUES, AND THE OUTCOME IS BASED ON THE SUBJECTIVE OPINION OF THE PATIENT. AT THE TWELVE-MONTH FOLLOW-UP, THE PATIENT REPORTED THAT THE DEVICE MOVES INTO THE BODY AND IS TOO FLEXIBLE WHEN ATTEMPTING SEXUAL INTERCOURSE. THE MOVEMENT INTO THE BODY SHORTENS THE LENGTH OF THE PENIS AND THE PATIENT IS UNABLE TO USE THE DEVICE. THE PHYSICIAN LATER SUSPECTED THE DEVICE WAS NOT WORKING AND DISCOVERED THE CYLINDERS WERE TOO SHORT AND LACKED RIGIDITY. THE PHYSICIAN REPLACED THE DEVICE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406480 ↗
• InjurySep 19, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT STATED THIS SPECTRA PENILE PROSTHESIS (SPP) WAS BENDING TOO EASILY; THEREFORE, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE SPP AND IMPLANT A MALLEABLE DEVICE AS PER THE PATIENT'S REQUEST. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257814 ↗
• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPECTRA PENILE PROSTHESIS (SPP) DEVICE WAS PENDING BILATERAL DISTAL EROSION. THE RIGHT SIDE WAS PENDING EROSION INTO THE URETHRA. THE LEFT SIDE WAS PENDING LATERAL EROSION. THE SPP DEVICE WAS EXPLANTED, AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) DEVICE WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Erosion

  MAUDE report 20217102 ↗
• InjuryAug 29, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED WITH HIS SPECTRA PENILE PROSTHESIS DEVICE BECAUSE IT WAS NOT RIGID ENOUGH FOR INTERCOURSE. THE SPP DEVICE WAS EXPLANTED, AND A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20104139 ↗