TACTRA 720081-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 08714729979357), received between Aug 22, 2019 and Aug 31, 2026 — classified as 137 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (27 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Malposition of Device

  It was reported that a patient implanted with a Tactra penile prosthesis experienced glans penile pain, loss of penile length, and glans instability. The patient also reported that the prosthesis was malpositioned relative to the glans. A penile ultrasound was performed and confirmed prosthesis malposition within the glans and glans instability, with the prosthesis noted to be poorly positioned in the glans. A revision procedure was scheduled to reconstruct the corpora cavernosa and replace the penile prosthesis. Subsequently, the revision surgery was performed, during which the Tactra penile prosthesis was explanted and replaced with an inflatable penile prosthesis (IPP). No additional patient complications were reported.

  Patient problems: Deformity/ Disfigurement; Pain

  MAUDE report 50515523 ↗
• InjuryAug 28, 2026Fracture; Mechanical Problem; Nonstandard Device; Material Deformation

  It was reported that the patient with this Tactra malleable penile prosthesis experienced axial instability of the device, difficulty achieving satisfactory penetration, and an unnatural feeling. Imaging did not identify suspected cross-over or fracture of the device. The patient also reported pain; however, the physician indicated that the pain was not specifically related to the prosthesis and was associated with the patient's prior clinical condition. Several days later, the device was explanted and replaced. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50489104 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA MALLEABLE PENILE PROSTHESIS EXPERIENCED AN INFECTION AT THE IMPLANT SITE, WITH FEVER AND REDNESS AT THE SITE. A BLOOD TEST WAS PERFORMED TO CONFIRM THE INFECTION. THE PHYSICIAN INDICATED THAT THE IMPLANTABLE MATERIAL AND THE OPEN PROCEDURE CONTRIBUTED TO THE INFECTION RISK. AN URGENT SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS EXPLANTED. THE INFECTION WAS TREATED WITH MEDICATIONS. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Erythema; Fever; Unspecified Infection

  MAUDE report 25361675 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA STATED THAT HIS DEVICE EXHIBITED SLIGHT CURVATURE, REQUIRING HIM TO TURN IT TO THE RIGHT DURING URINATION. THE PATIENT WAS EVALUATED AT A CLINIC, WHERE ANOTHER PHYSICIAN CONFIRMED THE PRESENCE OF SLIGHT CURVATURE AND NOTED THAT NON-ABSORBABLE SUTURES HAD BEEN USED DURING THE PROCEDURE. THESE SUTURES WERE EXPECTED TO REMAIN IN PLACE FOR APPROXIMATELY 90-100 DAYS AND COULD NOT BE REMOVED DUE TO PAIN AND TISSUE HEALING AT THE SITE. THE PATIENT EXPERIENCED PAIN AND SWELLING. THE DEVICE REMAINS IMPLANTED, AND THE PATIENT WAS ADVISED TO RETURN TO THE CLINIC IF THE CONDITION DOES NOT IMPROVE AND TO CONSIDER SEEKING A SECOND OPINION. A FOLLOW UP APPOINTMENT IS SCHEDULED FOR JULY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Deformity/ Disfigurement; Pain; Swelling/ Edema

  MAUDE report 25210924 ↗
• InjuryFeb 25, 2026Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH A TACTRA PENILE PROSTHESIS EXPERIENCED CRURAL PERFORATION. ADDITIONALLY, THE PATIENT WAS EXPERIENCING FUNCTIONAL DIFFICULTIES WITH THE DEVICE, INCLUDING INADEQUATE RIGIDITY AND BENDING. THESE DEFICIENCIES WERE CONFIRMED DURING A MEDICAL CONSULTATION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE TACTRA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24450074 ↗
• InjuryFeb 25, 2026Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WAS NOT SATISFIED WITH THE CONCEALABILITY OF THIS TACTRA IMPLANT. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH AN AMBICOR PENILE PROSTHESIS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442777 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH A TACTRA PENILE PROSTHESIS DEVICE EXPERIENCED PENILE PAIN AND DISCOMFORT. THE PHYSICIAN BELIEVES THE PAIN WAS DUE TO A CURVATURE OF THE PENIS FOR WHICH THE PATIENT HAD UNDERGONE A PENILE CURVATURE CORRECTION. THE TACTRA DEVICE WAS EXPLANTED, AND A NEW INFLATABLE PENILE PROSTHESIS (IPP) DEVICE WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Deformity/ Disfigurement; Discomfort; Pain

  MAUDE report 24046970 ↗
• InjuryDec 18, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA MALLEABLE PENILE PROSTHESIS WAS DISSATISFIED WITH THE DEVICE, STATING THAT IT FELT TOO SHORT. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839088 ↗
• InjuryDec 17, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED WITH HIS TACTRA DEVICE AND REQUESTED AN INFLATABLE PENILE PROSTHESIS (IPP) BECAUSE THE CYLINDERS DID NOT EXTEND TO THE GLANS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE TACTRA AND REPLACE IT WITH AN IPP. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825086 ↗
• InjuryDec 1, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED WITH THE PLACEMENT OF THE TACTRA DEVICE, AS THE CYLINDERS DID NOT EXTEND TO THE GLANS. CONSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23680034 ↗
• InjuryNov 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WITH A TACTRA DEVICE EXPERIENCED PAIN, AND UPON EVALUATION, THE DEVICE WAS FOUND TO HAVE FRACTURED IN HALF. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 23667633 ↗
• InjuryNov 20, 2025Fracture; Nonstandard Device; Fracture; Nonstandard Device

  IT WAS REPORTED THAT THIS TACTRA HAD A SINGLE CYLINDER FRACTURED AT THE SITE WHERE IT WAS ATTACHED TO THE ISCHIOPUBIC RAMUS WITH BONE ANCHORS. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE CYLINDER WAS REMOVED AND REPLACED WITH A NEW TACTRA CYLINDER. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605534 ↗
• InjuryNov 17, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THIS TACTRA WAS REMOVED AND REPLACED DUE TO PATIENT DISSATISFACTION WITH THE WAY THE DEVICE WAS POSITIONED AND FELT. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576300 ↗
• InjuryNov 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN TACTRA SURGERY DUE TO UNSPECIFIED REASONS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530932 ↗
• InjuryNov 5, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA DEVICE FELT IT WAS TOO SHORT AND NOTED THAT THE DISTAL END OF THE PENIS WAS FLOPPY, MAKING THE DEVICE DIFFICULT TO USE. THE DEVICE REMAINS IMPLANTED, AND A FOLLOW-UP APPOINTMENT HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23476520 ↗
• InjuryOct 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TACTRA REPLACEMENT SURGERY DUE TO PATIENT DISSATISFACTION. A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23346916 ↗
• InjuryOct 17, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA PENILE PROSTHESIS PRESENTED WITH CONCEALABILITY PROBLEMS, PAIN AND DISCOMFORT. IT WAS REPORTED THAT THE PATIENT IS NOT ABLE TO BEND IT. THE TACTRA DEVICE WAS EXPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 23322219 ↗
• InjuryOct 16, 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 DEVICE, EXPERIENCE AN INFECTION DUE TO THE PATIENT MISTAKENLY INJECTED IN HIS CORPUS CAVERNOUS TO HAVE A BETTER ERECTION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE TACTRA AND IMPLANT AN INFLATABLE PENILE PROSTHESIS (IPP). NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 23310873 ↗
• InjuryOct 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TACTRA SURGERY DUE TO UNSPECIFIED REASONS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280310 ↗
• InjurySep 25, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA MALLEABLE PENILE PROSTHESIS WAS DISSATISFIED WITH THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE TACTRA WAS EXPLANTED, AND AN INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23144167 ↗
• InjurySep 25, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA MALLEABLE PENILE PROSTHESIS WAS DISSATISFIED WITH THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE MALLEABLE IMPLANT WAS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143494 ↗
• InjurySep 23, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT WITH A TACTRA PENILE PROSTHESIS IS EXPERIENCING PAIN AND DISCOMFORT IN THE GLANS AREA, ATTRIBUTED TO MALPOSITIONING OF THE DISTAL TIP OF THE DEVICE. THIS HAS LED TO PENILE SIZE REDUCTION, GLANS DROOPING, AND LOSS OF ORGAN FUNCTIONALITY. AN ULTRASOUND WAS PERFORMED, AND SURGICAL INTERVENTION HAS BEEN SCHEDULED TO RECONSTRUCT THE CORPORA CAVERNOSA AND REPLACE THE PENILE PROSTHESIS. NO ADDITIONAL INFORMATION HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Deformity/ Disfigurement; Discomfort; Pain; Unspecified Tissue Injury

  MAUDE report 23129533 ↗
• InjurySep 17, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH A TACTRA MALLEABLE PENILE PROSTHESIS PRESENTED WITH INADEQUATE AXIAL RIGIDITY AND SIGNIFICANT PENILE DEFORMITY UPON MANIPULATION, ACCOMPANIED BY PAIN AND IMPROPER DEVICE FUNCTION DURING USE. DURING PHYSICAL EXAMINATION, THE PHYSICIAN OBSERVED ABNORMAL FLEXION OF THE PROSTHETIC SHAFT ON ONE SIDE, RESULTING IN A LOSS OF SYMMETRY AND SUPPORT. A STRUCTURAL ISSUE WITH THE DEVICE WAS SUSPECTED. A REPLACEMENT SURGERY WAS SCHEDULED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Deformity/ Disfigurement; Pain

  MAUDE report 23075846 ↗
• InjuryAug 27, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA WAS EXPERIENCING PAIN AND DISCOMFORT WHILE BENDING AND UNBENDING THE DEVICE. THE PROSTHESIS DID NOT ACHIEVE FULL FLEXION AND EXHIBITED A LOT OF RECOIL DURING MOVEMENT. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 22907719 ↗
• InjuryAug 13, 2025Mechanical Problem; Migration; Mechanical Problem; Migration

  IT WAS REPORTED DURING A FOLLOW-UP CONSULTATION, THAT THE PATIENT WITH A TACTRA MALLEABLE PENILE PROSTHESIS STATED THAT HE IS STILL UNABLE TO ACHIEVE SATISFACTORY SEXUAL ACTIVITY. THE DEVICE EXPERIENCED ROTATION OF THE RIGHT ROD ON ITS OWN AXIS, WHICH RESULTED IN TWISTED PENIS CAUSING PAIN. A REPLACEMENT SURGERY HAS BEEN SCHEDULED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Deformity/ Disfigurement; Pain

  MAUDE report 22800802 ↗