Spectra 720074-03Recalls & 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
Quick summary
This Spectra concealable penile prosthesis is a two-cylinder implant for erectile dysfunction. The 46 reports mostly describe implants breaking or bending so they lose rigidity, sometimes leaving the device fractured within the body, plus erosion through tissue and infection; some also describe the device feeling too small or too short. There are 40 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00878953005294), received between Aug 30, 2017 and Jun 29, 2026 — classified as 41 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem14
- Insufficient Device Problem Information12
- Mechanical Problem8
- Inadequacy of Device Shape and/or Size7
- Fracture5
- Migration3
- Component Missing1
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Erosion9
- Pain7
- No Information6
- Unspecified Infection5
- No Known Impact Or Consequence To Patient4
- Deformity/ Disfigurement2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 47 reports, 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 ↗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 ↗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 ↗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 ↗InjuryMay 27, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS UNDERSIZED AT THE TIP. AT IMPLANT, IT WAS BELIEVED THAT THE CORRECT SIZE DEVICE WAS IMPLANTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19400929 ↗MalfunctionAug 11, 2023Fracture; Noise, Audible; Fracture; Noise, Audible
IT WAS REPORTED THAT THIS SPECTRA PENILE PROSTHESIS EXHIBITED AXIAL INSTABILITY AND MADE NOISE WHEN BEING BENT. AN UNDEFINED FRACTURE OF THE DEVICE WAS NOTED. A REVISION SURGERY IS PLANNED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17510528 ↗InjuryApr 26, 2023Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A SPECTRA PENILE PROSTHESIS THAT WAS CAUSING DIFFICULTY WITH INTERCOURSE AND PAIN. UPON EXAMINATION, THE PHYSICIAN IDENTIFIED THAT THE DEVICE HAD RUPTURED ON THE RIGHT PROXIMAL SIDE AND THERE WAS INADEQUATE SPACING OF THE DEVICE. THERE HAS BEEN NO SURGICAL INTERVENTION AT THIS TIME.
Patient problems: Pain
MAUDE report 16817489 ↗MalfunctionMar 9, 2023Fracture; Mechanical Problem; Fracture; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY TO HAVE INTERCOURSE WITH SPECTRA DEVICE. A SPACING BETWEEN THE POLYMERS WAS NOTED VIA IMAGE EXAMINATION WHICH APPEARS LIKE A FRACTURE ON THE RIGHT-SIDE SPECTRA DEVICE, MEDIAL TO PROXIMAL REGION. A REVISION SURGERY WILL BE PERFORMED IN THE FUTURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16510403 ↗InjuryNov 16, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPECTRA PENILE PROSTHESIS DUE TO ISSUES RELATED TO THE AGE OF THE DEVICE. THE DEVICE WAS REMOVED AND REPLACED WITH AN AMBICOR PENILE PROSTHESIS (APP). THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15806372 ↗InjuryOct 10, 2022Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN SPECTRA CONCEALABLE PENILE PROSTHESIS REPLACEMENT SURGERY DUE TO CYLINDER MALPOSITION. IT IS SUSPECTED THAT THE DEVICE WAS OVERSIZED OR WAS NOT PLACED CORRECTLY INTO THE GLANS. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15570299 ↗InjuryAug 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN SPECTRA PENILE PROSTHESIS (SPP) REPLACEMENT SURGERY DUE TO UNSPECIFIED REASONS. DURING THE PROCEDURE, THE SPP WAS REMOVED AND A NEW TACTRA DEVICE WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15147928 ↗InjuryJun 22, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT WAS NOT SATISFIED WITH THIS SPECTRA DEVICE SINCE IT WAS NOT WORKING. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW AMBICOR PENILE PROSTHESIS (APP). THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14781370 ↗InjuryMay 7, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THE PATIENT HAD THE SPECTRA PENILE PROSTHESIS REPLACED WITH A TACTRA PENILE PROSTHESIS AS THE PATIENT WAS NOT SATISFIED WITH THE SIZE OF HIS IMPLANT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14328611 ↗InjuryFeb 11, 2022Fracture; Mechanical Problem; Fracture; Mechanical Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH THIS SPECTRA PENILE PROSTHESIS EXPERIENCED PAIN IN THE PENIS BASE AT THE RIGHT SIDE, WHICH LED TO A SURGICAL INTERVENTION APPROXIMATELY TWO WEEKS AFTER SYMPTOMS STARTED. DURING THE PROCEDURE, THE RIGHT CYLINDER WAS NOTED TO BE BROKEN. THE ENTIRE DEVICE WAS REPLACED WITH AN INFLATABLE PENILE PROSTHESIS. SURGERY OUTCOME WAS REPORTED AS SUCCESSFUL.
Patient problems: Pain
MAUDE report 13516782 ↗InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH THIS SPECTRA PENILE PROSTHESIS (SPP) STARTED EXPERIENCING DISCOMFORT DURING ONGOING USE OF THE DEVICE AND NOTED THAT THEIR GLANS LOOKED AS IF IT HAD ULCERATED, WHICH LED TO A CLINICAL EVALUATION. THE PHYSICIAN REMOVED THE SPP AND PERFORMED A BIOPSY IN THE AFFECTED AREA. THE PATIENT WAS EXPECTED TO FULLY RECOVER FROM THE PROCEDURE. NO ADDITIONAL INFORMATION WAS REPORTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT BIOPSY RESULTS, DESPITE GOOD FAITH EFFORTS.
Patient problems: Discomfort; Ulcer
MAUDE report 13386447 ↗InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS SPECTRA PENILE PROSTHESIS (SPP) DEVELOPED AN INFECTION OF UNKNOWN ETIOLOGY IN THE PENIS AREA, LEADING TO A REPLACEMENT PROCEDURE. THE DATE OF ONSET OF THE SYMPTOMS IS UNKNOWN. THE ENTIRE SPP WAS REPLACED WITH A TACTRA MALLEABLE PENILE PROSTHESIS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 13011587 ↗InjuryNov 12, 2021Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS SPECTRA PENILE PROSTHESIS (SPP) AS IT WAS SAID TO BE BROKEN. THE DEVICE WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12806780 ↗InjuryAug 19, 2021Mechanical Problem; Migration; Mechanical Problem; Migration
IT WAS REPORTED THAT THE DEVICE MIGRATED AND THE PATIENT HAD A FISTULA BETWEEN THE RIGHT CORPUS CAVERNOSUM AND THE DISTAL URETHRA AFTER HIS SPECTRA PENILE PROSTHESIS (SPP) IMPLANT. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT AND REPLACE HIS DEVICE ONE MONTH AFTER THE ORIGINAL PROCEDURE. THE EVENT WAS REPORTED AS RESOLVED.
Patient problems: Fistula
MAUDE report 12342726 ↗InjuryDec 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD A WORK ACCIDENT WHICH CAUSED THE SPECTRA INFLATABLE PENILE PROSTHESIS TO ERODE THROUGH HIS PENIS. THE IMPLANT WAS REMOVED IN (B)(6) 2019. A TACTRA 9.5MM WAS IMPLANTED ON (B)(6) 2020. THE PATIENT WAS DOING FINE FOLLOWING THE REIMPLANT SURGERY.
Patient problems: Erosion
MAUDE report 11061582 ↗InjuryNov 19, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN WITH SPECTRA PENILE PROSTHESIS (SPP). ALL COMPONENTS WERE EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO PRODUCT PERFORMANCE ISSUES.
Patient problems: Pain
MAUDE report 10867798 ↗InjuryAug 30, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIZING ISSUES WITH AN SPECTRA PENILE PROSTHESIS (SPP) AS THE DEVICE WOULD NOT REACH MID GLANS. A REPLACEMENT SURGERY WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS REMOVED AND A NEW SPP WAS IMPLANTED. THERE WERE NO DEVICE MALFUNCTIONS ASSOCIATED WITH THE EXPLANTED DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10469919 ↗InjuryAug 30, 2020Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATROPHY WITH A SPECTRA PENILE PROSTHESIS (SPP). THE ATROPHY WAS DIAGNOSED DURING TROUBLESHOOTING DUE TO A ROD BEING SHORTER THAN THE OTHER. A REPLACEMENT SURGERY WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS REMOVED AND A NEW MALLEABLE WAS IMPLANTED. DURING THE PROCEDURE IT WAS NOTED THAT THE PREVIOUS SPP WAS NOT ALL THE WAY TO THE TIPS OF THE GLANS. THE ROD HAD PROPER SIZING BUT IT WAS UPSIZED IN THE REVISION. THERE WERE NO MALPOSITION, DEVICE MALFUNCTIONS OR PATIENT COMPLICATIONS RELATED TO THE EXPLANTED DEVICE.
Patient problems: Tissue Damage
MAUDE report 10469916 ↗
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 720054-02American Medical Systems, Inc. · Prosthesis, Penile44 reports
- Genesis 91-9513SCColoplast A/S · PROSTHESIS, PENILE28 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.
How reports and recalls are matched · Editorial policy · Report an error on this page