TACTRA 720082-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 08714729979364), received between Aug 21, 2020 and Aug 20, 2026 — classified as 46 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Inadequacy of Device Shape and/or Size

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

  MAUDE report 50360037 ↗
• InjuryMar 3, 2026Nonstandard Device

  IT WAS REPORTED THAT A PATIENT WITH A TACTRA DEVICE EXPERIENCED DISSATISFACTION WITH THE DEVICE. THE PATIENT STATED THAT HE PREFERRED A THREE PIECE IMPLANT FOR IMPROVED CONCEALABILITY AND DID NOT LIKE THAT THE TACTRA REMAINED RIGID AT ALL TIMES. A REPLACEMENT SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED THE DEVICE AND REPLACED IT WITH A THREE PIECE IMPLANT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501081 ↗
• InjuryDec 31, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THIS TACTRA DEVICE APPEARED LOWER ON THE RIGHT SIDE COMPARED TO THE LEFT, SUGGESTING POSSIBLE INCORRECT SIZING. AS A RESULT, THE RIGHT CYLINDER WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933946 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA EXPERIENCED INFECTION AND FEVER. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO DEVICE ISSUES AND NOT FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 23865929 ↗
• InjuryDec 8, 2025Nonstandard Device; Migration; Nonstandard Device; Migration

  IT WAS REPORTED THAT A PATIENT WITH A TACTRA MALLEABLE DEVICE UNDERWENT REPLACEMENT SURGERY DUE TO DISSATISFACTION, STATING THAT THEY DID NOT LIKE THE DEVICE BEING RIGID AT ALL TIMES. DURING THE REVISION PROCEDURE, THE PHYSICIAN CONFIRMED DISTAL CROSSOVER FROM THE PRIOR IMPLANTATION. THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED WITH A THREE-PIECE INFLATABLE DEVICE. THE PHYSICIAN STATED BEING EXTREMELY CAUTIOUS WHEN PLACING THE CYLINDERS AND ENSURING THEY REMAINED IN THEIR RESPECTIVE SPACES. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23751529 ↗
• MalfunctionOct 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH A TACTRA DEVICE PRESENTED WITH FLUID DISCHARGE. A REPLACEMENT SURGERY HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Fluid Discharge; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377673 ↗
• InjurySep 2, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH A TACTRA MALLEABLE PENILE PROSTHESIS STATED THAT HE ALWAYS HAS AN ARC IN HIS PENIS, AND WHEN HE TRIES TO MOVE IT, IT PIVOTS AND BENDS TO THE LEFT. NO REVISION SURGERY HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22935460 ↗
• InjuryMay 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA DEVICE EXPERIENCED DISCOMFORT, PAIN AND SENSITIVITY INSIDE THE TIP OF THE PENIS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Discomfort; Nerve Damage; Pain

  MAUDE report 22090506 ↗
• InjuryMay 9, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH A TACTRA STATED THAT HE FEELS THE LEFT SIDE BENDS TO THE LEFT CREATING A "C" SHAPE. HE MENTIONED THAT HE PREFERS HOW HIS ORIGINAL SPECTRA DEVICE FELT. ADDITIONALLY, HE STATED THAT HE FEELS THE LEFT CYLINDER MOVES OR SPINS, HOWEVER, THE PHYSICIAN HAS NOT CONFIRMED ANY MOVEMENT OF THE PROSTHESIS. THE PATIENT DISCUSSED THIS WITH HIS DOCTOR, AND HIS DOCTOR RECOMMENDED AN INFLATABLE PENILE PROSTHESIS (IPP), WHICH HE DOES NOT WANT. THE PATIENT SERVICES SPECIALIST SUGGESTED HIM TO GET A SECOND OPINION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21993367 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A MALLEABLE IN FROM A PRIOR INFECTION AND WANTED AN INFLATABLE BACK IN. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM FOR AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 21909539 ↗
• InjuryMar 26, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA PENILE PROSTHESIS PRESENTED WITH PAIN AND AN INABILITY TO PENETRATE. THE DEVICE WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 21700552 ↗
• InjuryMar 4, 2025Defective Device; Migration; Defective Device; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA MALLEABLE PENILE PROSTHESIS EXPERIENCED PAIN DURING INTERCOURSE. PHYSICAL EXAMINATION REVEALED A BENDING OF ONE OF THE PROSTHESIS RODS, WITH THE PROXIMAL PORTION POSITIONED CONTRALATERALLY; THEREFORE, A REVISION SURGERY WAS SUGGESTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 21516690 ↗
• InjuryFeb 24, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT COULD NOT VOID, AND THE DEVICE SEEMED TO FIT ORIGINALLY BUT REALIZED AFTER THE SURGERY THAT IT WAS TOO BIG. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM FOR A SMALLER ONE.

  Patient problems: Urinary Retention

  MAUDE report 21447040 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA MALLEABLE PROSTHESIS EXPERIENCED INFECTION IN THE PENIS. THE PATIENT WAS HOSPITALIZED FOR INTRAVENOUS ANTIBIOTIC THERAPY AWAITING A SURGICAL PROCEDURE TO REMOVE AND REPLACE THE INFECTED PROSTHESIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 21054925 ↗
• InjuryDec 10, 2024Defective Device; Malposition of Device; Defective Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA DEVICE EXPERIENCED PENILE DEFORMITY AND DISCOMFORT, ATTRIBUTED TO EXCESSIVE CURVATURE OF THE DEVICE. THE PHYSICIAN SUSPECTS THAT THIS CURVATURE MAY BE DUE TO THE NITINOL'S MEMORY PROPERTIES. IN ADDITION, IT WAS NOTED THAT THE DEVICE WAS MISPOSITIONED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE TACTRA AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Deformity/ Disfigurement; Discomfort

  MAUDE report 20893748 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TACTRA REVISION SURGERY DUE TO UNSPECIFIED REASONS. THE TACTRA DEVICE WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20782824 ↗
• InjuryOct 23, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT WITH HIS TACTRA PENILE PROSTHESIS DEVICE BECAUSE IT WOULD NOT GET FLACCID ENOUGH. THE TACTRA DEVICE WAS EXPLANTED, AND A NEW INFLATABLE PENILE PROSTHESIS DEVICE WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Discomfort

  MAUDE report 20518973 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA PENILE PROSTHESIS PRESENTED WITH AN INFECTION AT THE IMPLANT SITE TWO MONTHS POST PROCEDURE. THE PATIENT NOTICED A SMALL SECRETION FROM THE INCISION SITE, WHICH WAS TREATED WITH ANTIBIOTICS, BUT WAS UNSUCCESSFUL. AN EVALUATION REVEALED THE BEGINNING OF A POSSIBLE CYLINDER PROSTHESIS EXTRUSION THROUGH A CAVERNOUS FISTULA. THE TACTRA DEVICE IS CURRENTLY IMPLANTED, AND THE REPLACEMENT SURGERY IS ALREADY BOOKED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Fluid Discharge; Unspecified Infection

  MAUDE report 20514533 ↗
• InjurySep 16, 2024Migration; Migration

  IT WAS REPORTED THAT THIS TACTRA MALLEABLE PENILE PROSTHESIS MIGRATED PROXIMALLY. THE PATIENT UNDERWENT SURGERY IN ORDER TO REPLACE THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233456 ↗
• InjuryAug 28, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA PENILE PROSTHESIS EXPERIENCED MIGRATION OF THE LEFT CYLINDER AND POSSIBLE PERFORATION OF THE LEFT PROXIMAL CORPUS CAVERNOSUM. SURGICAL INTERVENTION IS ANTICIPATED FOR (B)(6) 2024. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Perforation

  MAUDE report 20089017 ↗
• MalfunctionApr 10, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS MALLEABLE DEVICE IS NOT PERFORMING AS EXPECTED AS THE DEVICE KEEPS GETTING CROSSED WHEN USING IT. THE DEVICE REMAINS IMPLANTED, AND NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19083779 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA PENILE PROSTHESIS PRESENTED WITH AN INFECTION. THE TACTRA WAS EXPLANTED, THE AREA WAS WASHED OUT, AND A NEW TACTRA WAS IMPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 18881933 ↗
• InjuryNov 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS TACTRA MALLEABLE PENILE PROSTHESIS WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS DUE TO UNSPECIFIED REASONS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223078 ↗
• InjuryApr 26, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT IN THE GLANS WITH A TACTRA DEVICE. THE PHYSICIAN DETERMINED THAT THE DEVICE WAS AN IMPROPER SIZE FOR THE PATIENT AND WAS EXPLANTED. A NEW SHORTER TACTRA WAS IMPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort

  MAUDE report 16814550 ↗
• InjuryJan 3, 2023Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS TACTRA DEVICE WAS NOT USED AND INSTEAD, AN AMBICOR PENILE PROSTHESIS (APP) WAS USED SINCE IT WAS A BETTER FIT FOR THE PATIENT. ALSO, A PROXIMAL PERFORATION WAS NOTED DURING SURGERY. THE REAR TIPS WERE SUTURED TO THE CORPORA TO LET THE PATIENT HEAL SINCE THIS PERFORATION WAS UNKNOWN UNTIL THE TIME OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Perforation

  MAUDE report 16087615 ↗