Spectra 720074-01Recalls & 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
Quick summary
This American Medical Systems Spectra concealable penile prosthesis has 23 adverse event reports, with no deaths and 21 injuries. Reports mostly describe the implant bending too easily during intercourse, being the wrong size, breaking, or shifting out of position, usually leading to surgery to remove or replace it. 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
- 22
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00878953005270), received between Jan 25, 2018 and Dec 5, 2024 — classified as 20 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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
- Insufficient Device Problem Information7
- Inadequacy of Device Shape and/or Size3
- Mechanical Problem3
- Break2
- Defective Device2
- Device Operates Differently Than Expected1
- Inflation Problem1
- Material Puncture/Hole1
Patient problems
- No Known Impact Or Consequence To Patient7
- No Clinical Signs, Symptoms or Conditions4
- No Information2
- Pain2
- Unspecified Infection2
- Deformity/ Disfigurement1
- Depression1
- Erosion1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryMar 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO IMPLANT THIS SPECTRA PENILE PROSTHESIS. AFTER THE PROCEDURE, THE PATIENT DEVELOPED A CUTANEOUS FUNGAL INFECTION AT THE INCISION SITE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 18937699 ↗InjuryMar 1, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT HAD THE SPECTRA PENILE PROSTHESIS REMOVED AS IT BENT MAKING INSERTION DURING INTERCOURSE DIFFICULT. A NEW TACTRA PENILE PROSTHESIS WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16459493 ↗InjuryFeb 8, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THIS UNDERSIZED SPECTRA PENILE PROSTHESIS (SPP). DURING SURGERY, IT WAS NOTED THAT THERE WAS PENDING LATERAL EROSION IN THE PENIS, WHICH IS BELIEVED TO BE RELATED TO THE SIZING ISSUES. THE ENTIRE SPP WAS REMOVED AND REPLACED WITH A INFLATABLE PENILE PROSTHESIS. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Erosion
MAUDE report 13490183 ↗InjuryJun 3, 2021Defective Device; Defective Device
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SPECTRA PENILE PROSTHESIS (SPP) INSERTION DIFFICULTIES AS THE DEVICE WOULD BEND DURING INTERCOURSE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING SPP WAS REMOVED AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. THE PATIENT WAS STABLE AND IMPROVED FOLLOWING THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11929715 ↗InjuryOct 28, 2020Break; Break
IT WAS REPORTED THAT THE SPECTRA PENILE PROSTHESIS (SPP) DEVICE WAS EXPLANTED BECAUSE BOTH CYLINDERS WERE BROKEN. THE DEVICE ISSUES BEGAN IN (B)(6) 2020. A NEW SPP DEVICE WAS IMPLANTED. AFTER THE SURGERY THE PATIENT HAS BEEN SEEN EVERY DAY TO EVALUATE IS CONDITION AND ENSURE THERE IS NO INFECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10751658 ↗InjuryOct 26, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT AFTER 6 MONTHS OF IMPLANTATION, THE PATIENT COMPLAINED THAT THE PROSTHESIS WAS NOT ABLE TO SUPPORT THE PENIS DURING SEXUAL INTERCOURSE, HAPPENING TO GIVE IN LATERALLY (COLLAPSING), MAKING HIM UNABLE TO HAVE INTERCOURSE. THE PATIENT IS DISSATISFIED AND REQUESTING A REVISION SURGERY. THE PATIENT HAD THE AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP) REPLACED AS THE PATIENT HAD PENILE PAIN AND THE PROSTHESIS WAS COLLAPSING ON ITS OWN AXIS.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 10738005 ↗InjuryMar 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT INDICATED PENIS "PULLING" TO THE RIGHT WITH AN SPECTRA PENILE PROSTHESIS (SPP). THE SUSPECTED CAUSE WAS SCAR TISSUE NEAR THE CORPORA. NO SURGICAL PROCEDURE HAS BEEN PERFORMED. IT WAS FURTHER REPORTED THAT THERE WERE NO DEVICE MALFUNCTIONS ASSOCIATED WITH THE DEVICE. NO MORE INFORMATION AVAILABLE AT THE MOMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED.
Patient problems: Scarring
MAUDE report 9908119 ↗MalfunctionJan 3, 2020Break; Inadequacy of Device Shape and/or Size; Break; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT WAS SUBMITTED SPECTRA PROSTHESIS IMPLANTATION ON (B)(6) 2019. DURING DILATION, WE REACHED THE 14-15 CALIBER BUT THE MOST CALIBER PROSTHESIS AVAILABLE WAS 12 CALIBER. THE PROSTHESIS IS PLACED IN SITU BUT THE PATIENT IS QUITE DISAPPOINTED AND DISSATISFIED AS IT IS COMPLAINED THAT THE PROSTHESIS DOES NOT PROVIDE THE STIFFNESS. NECESSARY FOR SATISFACTORY PENETRATION AND RELATIONSHIP. THE PATIENT REPORTS SHAME AND POST-SURGICAL DEPRESSION DUE TO THE INEFFECTIVENESS OF THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED A 14 MM CYLINDER WASN'T AVAILABLE AS IT WAS NOT STANDARD PRACTICE TO HAVE THAT SPECIFIC SIZE IN STOCK. INTERVENTION OR A REVISION SURGERY HAS NOT BEEN SCHEDULED YET. THE DEVICE FUNCTION LOOKED GOD AT THE TIME OF THE IMPLANT, BUT THE PATIENT COMPLAINED THAT THE PENIS WITHOUT SUSTAINING AND THE PENIS DOUBLE OF THE RELATIONSHIP TIME. DURING X-RAY, IT WAS NOTED THAT THE DEVICE NEEDS TO BE A 14 MM DEVICE BECAUSE IT WAS BROKEN WITHIN THE CAVE'S BODY.
Patient problems: Depression
MAUDE report 9546773 ↗InjuryNov 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THE MALLEABLE PENILE PROSTHESIS REMOVED DUE TO AN OLD IMPLANT. A NEW INFLATABLE PENILE PROSTHESIS (IPP) CONSISTING OF CYLINDERS, PUMP, AND RESERVOIR WERE IMPLANTED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WANTED TO REPLACE FROM OLD TO IPP. THE PATIENT FELT IT WAS INCONVENIENT COMPARE WITH IPP. NO SPECIFIC CAUSE WAS FOUND.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9368713 ↗InjuryAug 5, 2019Migration; Migration
IT WAS REPORTED THAT DUE TO MIGRATION THE PATIENT WILL HAVE HIS SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP) REVISED ON A FUTURE DATE. THE PATIENT WAS DISCHARGED 60 POSTOPERATIVE DAYS FOR SEXUAL INITIATION. AFTER 2 WEEKS THE PATIENT NOTICED A MIGRATION OF THE PROTHESIS. AFTER CONSULTATION IT WAS NOTED THAT THE PROSTHESIS LEFT SIDE WAS POSITIONED 4 CM BELOW THE END OF THE CAVERNOUS BODY IN ITS DISTAL PORTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IT WAS FURTHER REPORTED THAT THIS PATIENT IS EXPERIENCING A LOT OF PAIN. IT WAS FURTHER REPORTED THAT THIS PATIENT HAS HIS SPP REMOVED AND REPLACED. A NEW 12MMX20CM SPP WAS IMPLANTED.
Patient problems: Pain
MAUDE report 8861435 ↗InjuryApr 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERAL INFECTIONS WITH A SPECTRA IMPLANT. THE OLD IMPLANTED DEVICE WAS REMOVED AND A NEW ONE WAS IMPLANTED. A PATIENT OUTCOME WAS NOT REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED AND IS NOT YET AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Unspecified Infection
MAUDE report 8500425 ↗MalfunctionMar 16, 2019Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT A HOLE WAS FOUND IN A NEW SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP) WHEN THE IMPLANT BOX WAS OPENED FOR A PATIENT SURGICAL PROCEDURE. THE PATIENT WAS IMPLANTED WITH ANOTHER NEW SPP. THE PRODUCT WAS EXPLANTED AND EXPECTED TO BE RETURNED. A SUPPLEMENTAL REPORT WILL BE FILED AFTER THE PRODUCT HAS BEEN RETURNED AND PRODUCT ANALYSIS HAS BEEN COMPLETED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8427137 ↗InjuryDec 10, 2018Inflation Problem; Inflation Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE PUMP NOT INFLATING WITH A SPECTRA PENILE PROSTHESIS (SPP). THE SPP WAS EXPLANTED AND A NEW CXR INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. DURING THE IMPLANT PROCEDURE, THE FIRST CYLINDER THAT WAS ATTEMPTED WAS NOT IMPLANTED DUE TO MEASUREMENT ERROR AND THE CYLINDER WAS TOO THICK TO ADVANCE TO THE CORPUS CAVERNOSUM AND A NEW IPP CYLINDER WAS IMPLANTED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8148665 ↗InjuryNov 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSPECIFIED ISSUE WITH SPECTRA CONCEALABLE PENILE PROSTHESIS (SPP). SPP LEFT CYLINDER OF 9.5MM BY 12CM AND SPP RIGHT CYLINDER OF 12MM BY 12MM WERE IMPLANTED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8104011 ↗InjuryOct 12, 2018Use of Device Problem; Use of Device Problem
IT WAS REPORTED THE PATIENT HAD A SPECTRA PENILE PROSTHESIS IMPLANTED ON (B)(6) 2018 AT WHICH TIME THEY ONLY IMPLANTED THE RIGHT CYLINDER. THE LEFT CYLINDER WAS NOT IMPLANTED. THE SPECTRA PROSTHESIS IS DESIGNED TO BE IMPLANTED AS A PAIR OF MATCHED CYLINDERS. A SINGLE IMPLANTED CYLINDER MAY NOT BE ADEQUATE TO ACHIEVE SEXUAL INTERCOURSE AND MAY HAVE AN ADVERSE EFFECT ON THE RELIABILITY OF THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7960832 ↗InjuryMay 15, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS REPLACED WITH AN INFLATABLE PENILE PROSTHESIS DUE TO PATIENT DISSATISFACTION AS THE PATIENT FELT THE DEVICE WAS NOT RIGID ENOUGH. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: Therapeutic Response, Decreased
MAUDE report 7516219 ↗InjuryApr 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS REMOVED AND REPLACED DUE TO UNSPECIFIED REASONS. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Information
MAUDE report 7433183 ↗InjuryMar 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S SPECTRA PENILE PROSTHESIS WAS REPLACED WITH AN INFLATABLE PENILE PROSTHESIS FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Information
MAUDE report 7384578 ↗InjuryFeb 13, 2018Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE A REVISION SURGERY ON HIS SPECTRA PENILE PROSTHESIS DUE TO THE PATIENT "PRESENTED INCONVENIENCES WITH THE DEVICE." NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: Failure of Implant
MAUDE report 7268587 ↗InjuryJan 25, 2018Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS (SPP) REMOVED AND REPLACED DUE TO AN UNSPECIFIED REASON. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT HAD HIS SPP REMOVED ON AN UNKNOWN DATE, AND THEN ON (B)(6) 2017, THIS PATIENT WAS RE-IMPLANTED WITH ANOTHER SPP. THIS PATIENT HAD TO HAVE AN EMERGENCY REMOVAL DUE TO THE DEVICE "WENT THROUGH THE CORPUS CAVERNOSUM." IT WAS ADDED THAT ¿THE PATIENT¿S CONDITION WAS SERIOUS AND IT WAS QUITE URGENT.¿
Patient problems: Perforation
MAUDE report 7220613 ↗
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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