Spectra 720074-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00878953005287), received between Aug 29, 2017 and Dec 16, 2025 — classified as 86 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (33 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, 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

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR THE REMOVAL OF HIS SPECTRA PENILE PROSTHESIS, A TACTRA MALLEABLE PROSTHESIS WAS IMPLANTED. THE REASON FOR REPLACEMENT WAS NOT DISCLOSED. THERE WERE NO DEVICE ISSUES REPORTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543456 ↗
• InjuryMay 10, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS SPECTRA CONCEALABLE PENILE PROSTHESIS WAS DISSATISFIED AS THEY HAD A FLOPPY GLANS. THE PHYSICIAN REMEASURED THE DEVICE AND REPLACED WITH A 11 MM TACTRA AND PERFORMED PENOPLASTY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286927 ↗
• MalfunctionMar 14, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED IMPOSSIBILITY OF PENETRATION DURING INTERCOURSE. THE SPECTRA PENILE PROSTHESIS WAS WELL PLACED, BUT WAS BENDING AND EXTREMELY MALLEABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904483 ↗
• InjurySep 13, 2023Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INFLATABLE PENILE PROSTHESIS REPLACEMENT SURGERY AS THE DEVICE BENT DURING SEXUAL INTERCOURSE AND IT WAS DIFFICULT TO INSERT. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE FOLLOWING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736339 ↗
• InjuryMay 24, 2023Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SPECTRA PENILE PROSTHESIS (SPP) WAS REPLACED DUE TO THE DEVICE NO LONGER STAYING ERECT AND SEEMED TO BE WORN OUT. THE PATIENT HAD THE SPP IMPLANTED 14 YEARS AGO. THE DEVICE WAS REMOVED AND REPLACED WITH A TACTRA DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16998612 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE SPECTRA PENILE PROSTHESIS DUE TO INFECTION. A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16756085 ↗
• MalfunctionDec 15, 2022Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MECHANICAL PROBLEMS WITH THIS SPECTRA DEVICE, AS THE PROSTHESIS APPEARS TO BE BROKEN AT THE BASE. A SURGICAL PROCEDURE WAS PERFORMED AND THE SPECTRA WAS REMOVED AND REPLACED WITH A TACTRA DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991000 ↗
• InjuryDec 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH A SPECTRA PENILE PROSTHESIS REQUIRES SURGICAL INTERVENTION FOR UNSPECIFIED REASONS. THERE HAS BEEN NO SURGICAL INTERVENTION OR PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973663 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SOME NECROSIS AT THE INCISION SITE AND BLEEDING BUT NOT MORE THAN EXPECTED; THEREFORE, THE PATIENT WAS WATCHED OVER THE WEEKEND. IN ADDITION, A SMALL HEMATOMA WAS FOUND IN THE CORPORAL BODY. DUE TO THE MEDICAL HISTORY OF THE PATIENT, THE PHYSICIAN DECIDED TO REMOVE THE SPECTRA PENILE PROSTHESIS (SPP). THERE WERE NO PERFORMANCE ALLEGATIONS AGAINST THE DEVICE. THE DEVICE IS NOT SUSPECTED TO BE RELATED TO THE PATIENT HEALTH CONDITION.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Necrosis

  MAUDE report 15325287 ↗
• InjuryJul 5, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD THIS TACTRA DEVICE REPLACED WITH A SPECTRA SINCE THE PATIENT CLAIMED DISSATISFACTION AS THE DEVICE WAS NOT FIRM ENOUGH DURING INTERCOURSE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14918302 ↗
• InjuryJun 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS SPECTRA PENILE PROSTHESIS (SPP) FOR UNSPECIFIED REASONS. ALL COMPONENTS OF THE EXISTING SPECTRA WERE EXPLANTED AND REPLACED WITH A NEW TACTRA MALLEABLE PENILE PROSTHESIS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854520 ↗
• InjuryMay 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO HAVE A SPECTRA PENILE PROSTHESIS (SPP) EXPLANTED AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) IMPLANTED FOR UNSPECIFIED REASONS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14350353 ↗
• InjuryMar 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGERY TO HAVE AN SPECTRA PENILE PROSTHESIS (SPP) EXPLANTED DUE TO UNSPECIFIED REASONS. A NEW SPP WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  MAUDE report 13764806 ↗
• InjuryFeb 23, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THIS SPECTRA PENILE PROSTHESIS (SPP) DID NOT REMAIN ERECT DURING PENETRATION. WHEN THE PROSTHESIS BENT, IT CAUSED PAIN TO THE PATIENT AND THEIR PARTNER. THE PHYSICIAN SUBMITTED A REQUEST TO REPLACE THE SPP WITH A TACTRA MALLEABLE PROSTHESIS. RECORDS DO NOT INDICATE THE PROCEDURE HAS OCCURRED.

  Patient problems: Pain

  MAUDE report 13588937 ↗
• InjuryJan 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD THE SPECTRA PENILE PROSTHESIS REMOVED DUE TO PAIN. A NEW CXR INFLATABLE PENILE PROSTHESIS. FOLLOWING THE SURGERY, THE EVENT RESOLVED.

  Patient problems: Pain

  MAUDE report 13151483 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE SPECTRA PENILE PROSTHESIS REMOVED DUE TO AN INFECTION. A NEW TACTRA PENILE PROSTHESIS WAS IMPLANTED. FOLLOWING THE SURGERY, THE PATIENT WAS STABLE AND THE EVENT RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 13100392 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WITH HIS SPECTRA PENILE PROSTHESIS (SPP). A SURGERY WAS PERFORMED AND THE SPP WAS REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Pain

  MAUDE report 13018019 ↗
• InjuryNov 29, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REPLACEMENT SURGERY DUE TO LOSS OF FIRMNESS OF THIS SPECTRA PENILE PROSTHESIS (SPP) WHICH MADE SEXUAL INTERCOURSE WAS IMPOSSIBLE. A NEW MALLEABLE PROSTHESIS WAS IMPLANTED. THE PATENT HAD A STABLE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885326 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT CYLINDER EXTRUSION THROUGH THE URETHRA WITH A SPECTRA PENILE PROSTHESIS (SPP). A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE CYLINDER WAS REMOVED. IT WAS INDICATED THAT THE RIGHT CYLINDER REMAINED IMPLANTED AS THE ERECTION WAS STILL SATISFACTORY. IT WAS INDICATED THAT THERE WAS NO PENILE TRAUMA OR SEXUAL INTERCOURSE WITH EXAGGERATED FORCE LEADING TO THE EXTRUSION.

  Patient problems: Erosion; Perforation

  MAUDE report 12833161 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT CYLINDER EXTRUSION THROUGH THE URETHRA WITH A SPECTRA PENILE PROSTHESIS (SPP). A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE CYLINDER WAS REMOVED. IT WAS INDICATED THAT THE RIGHT CYLINDER REMAINED IMPLANTED AS THE ERECTION WAS STILL SATISFACTORY. A MONTH LATER, THE REMAINING ROD EXTRUDED THROUGH THE URETHRA. IT WAS INDICATED THAT THERE WAS NO PENILE TRAUMA OR SEXUAL INTERCOURSE WITH EXAGGERATED FORCE LEADING TO THE EXTRUSION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Erosion; Perforation

  MAUDE report 12833026 ↗
• InjuryAug 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REPLACEMENT SURGERY DUE TO UNSPECIFIED REASONS. DURING THE PROCEDURE, THE EXISTING SPECTRA PENILE PROSTHESIS (SPP) WAS REMOVED AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353005 ↗