Spectra 720054-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00878953005201), received between Sep 8, 2017 and Aug 7, 2023 — classified as 17 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY BECAUSE THE RIGHT CYLINDER OF THE SPECTRA PENILE PROSTHESIS (SPP) WAS MALPOSITIONED. THE SPP WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476653 ↗
• MalfunctionJul 28, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT REPORTED TO THE PHYSICIAN THAT HE HAD DIFFICULTY, FOLLOWING THE IMPLANT, TO MAINTAIN RIGIDITY WITH THE SPECTRA PENILE PROSTHESIS WHEN USED. THERE WAS ALSO SUBSTANTIAL WORSENING OF RIGIDITY OVER TIME AND THAT COMPLETELY LOST RIGIDITY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121494 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS SPECTRA PENILE PROSTHESIS (SPP) EXPERIENCED PAIN AT THE SURGICAL SITE, WHICH LED TO A SURGICAL INTERVENTION. DURING THE PROCEDURE, THE SPP WAS REMOVED AND REPLACED WITH A TACTRA MALLEABLE PENILE PROSTHESIS. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 14079803 ↗
• InjuryFeb 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFLAMMATION. TWO WEEKS LATER HIS SPECTRA PENILE PROSTHESIS (SPP) DEVICE WAS EXPLANTED. THE PATIENT WAS LATER IMPLANTED WITH A NEW INFLATABLE PENILE PROSTHESIS (IPP) DEVICE ON (B)(6) 2022. FOLLOWING IMPLANTATION WITH THE IPP DEVICE THE PATIENT'S CONDITION IMPROVED.

  Patient problems: Inflammation

  MAUDE report 13507272 ↗
• InjuryDec 3, 2021Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY TO REPLACE THE SPECTRA MALLEABLE PENILE PROSTHESIS DUE TO UNSPECIFIED REASON. AN INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924670 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION OF HIS SPECTRA PENILE PROSTHESIS (SPP). A SURGERY WAS PERFORMED IN WHICH THE PROSTHESIS WAS PERFORMED AND ONE SPP CYLINDER WAS IMPLANTED. THE PATIENT HAD A GOOD OUTCOME WITH ONE CYLINDER REMAINING AFTER INSERTION.

  Patient problems: Unspecified Infection

  MAUDE report 12923456 ↗
• InjuryDec 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A SURGICAL PROCEDURE INVOLVING HIS SPECTRA PENILE PROSTHESIS (SPP) DUE TO UNKNOWN REASONS. ALL COMPONENTS WERE EXPLANTED AND REPLACED. WITH A NEW INFLATABLE PENILE PROSTHESIS (IPP).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11008797 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS (SPP) REMOVED DUE TO PAIN IN THE GLANS OR SCROTUM. THE PAIN ORIGINATED IN THE SOFT TISSUE BECAUSE OF THE PUMP. THE PHYSICIAN FEELS THE PAIN WAS CAUSED BY THE PATIENT'S INFECTION. THE PATIENT STATUS FOLLOWING THIS SURGERY WAS "NOT BAD."

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 10905592 ↗
• InjuryJul 17, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE IS A SYSTEM FAILURE OF THE SPECTRA PENILE PROSTHESIS (SPP) DEVICE AND BECAUSE THE "IMPLANT DEFLECTED." IT WAS FURTHER REPORTED THE SYSTEM FAILURE WAS THE PATIENT'S "INABILITY TO END A SEXUAL INTERCOURSE." THE PATIENT'S PENIS WAS DEFLECTION TO THE LEFT SIDE DUE TO THE PROSTHESIS. IT IS PLANNED THAT THE THAT THE REVISION WILL BE PERFORMED ON (B)(6) 2019. IT WAS ALSO FURTHER REPORTED THAT THE SPP WAS EXPLANTED AND A NEW 16 CM AMBICOR PENILE PROSTHESIS (APP) DEVICE WAS IMPLANTED. THE OUTCOME OF THE SURGERY WAS SUCCESSFUL. THE PATIENT IS UNDER OBSERVATION UNTIL THE IMPLANT IS ACTIVATED.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 8799182 ↗
• MalfunctionJun 10, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN MEASURED 16.5CM AND USED 12 CM X 9.5MM CYLINDER WITH REAR TIPS OF 1.5 CM AND 3 CM. THE PHYSICIAN USED IT TO MAKE THE INCISION SMALLER DURING INSERTION, AND THE SURFACE OF CYLINDER WAS TORN IN THE PROCESS OF PUTTING IN THE CYLINDER HARD. THEY DID NOT HAVE THE SAME SIZE, SO THE PHYSICIAN ASKED FOR PREPARATION OF A 16 CM X 9.5 MM WITH A REAR TIP 0.5 CM TO FINISHED THE SURGERY. THE EVENT RESOLVED AND THE PATIENT WAS STABLE. 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 8682778 ↗
• InjuryDec 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ORIGINAL SPECTRA MALLEABLE PENILE PROSTHESIS IMPLANT SURGERY, ONLY THE LEFT 12 CM X 9.5 CM CYLINDER WAS IMPLANTED FOR UNKNOWN REASONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8143436 ↗
• InjuryNov 27, 2018Inadequacy of Device Shape and/or Size; Defective Device; Migration; Inadequacy of Device Shape and/or Size; Defective Device; Migration

  IT WAS REPORTED THAT THE PATIENT'S SPECTRA PENILE PROSTHESIS WAS TOO SHORT. THE LEFT CYLINDER WAS OUTSIDE OF THE CORPORA DISTALLY. THE PATIENT WAS DISSATISFIED THAT THERE WAS NO GIRTH EXPANSION. THE PATIENT'S DISSATISFACTION STARTED SHORTLY AFTER IMPLANT. THE DEVICE WAS REPLACED WITH AN AMS 700 INFLATABLE PENILE PROSTHESIS. THE PATIENT HAD NO KNOWN CONCERNS FOLLOWING REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109049 ↗
• 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 8104087 ↗
• InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS REMOVED AND REPLACED WITH A SPECTRA PENILE PROSTHESIS DUE TO EROSION AND "RIGHT SIDE FELL OUT." NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Erosion

  MAUDE report 7850046 ↗
• InjuryAug 24, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS RIGHT CYLINDER REMOVED AND REPLACED DUE TO RIGHT CYLINDER MIGRATED PROXIMALLY. IT WAS ADDED THAT THE PHYSICIAN DECIDED TO REMOVE THE OLD CYLINDER AND PLACE A NEW ONE UTILIZING A SLING PROCEDURE TO SECURE IT TO THE COPRA AND PREVENT IT FROM MIGRATING PROXIMALLY. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Information

  MAUDE report 7812220 ↗
• InjuryMay 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED ON 03-MAY-2018 INDICATED THAT THE COMPLAINT WAS NOT REPORTABLE. INFORMATION WAS RECEIVED THAT THE PREVIOUS SPECTRA WAS "TOO SMALL" AND WAS REPLACED WITH A "LONGER AND THICKER DEVICE." NO REPORT IS REQUIRED BECAUSE DEVICE SIZING IS INCLUDED IN THE IFU AND OPERATING ROOM MANUAL. IF THE DEVICE IS TOO SMALL IT WOULD NOT CONTRIBUTE TO A SERIOUS INJURY AND THERE'S NO INDICATION OF A DEVICE MALFUNCTION.

  Patient problems: No Information

  MAUDE report 7486130 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD HIS LEFT SPECTRA PENILE PROSTHESIS CYLINDER REMOVED DUE TO GLANS PERFORATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Perforation

  MAUDE report 7272536 ↗
• InjuryDec 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS DUE TO PATIENT DISSATISFACTION. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Information

  MAUDE report 7100651 ↗
• InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD HIS SPECTRA PENILE PROSTHESIS REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 6851055 ↗