TACTRA 720080-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 08714729979340), received between Nov 8, 2019 and Aug 20, 2026 — classified as 57 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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 61 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Insufficient Device Problem Information

  It was reported that a patient underwent a surgery to remove the Tactra and replace with an Inflatable Penile Prosthesis (IPP) due to unspecified reasons. No patient complications were reported in relation to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351131 ↗
• InjuryJun 10, 2026Nonstandard Device

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A TACTRA DEVICE EXHIBITED CONCEALABILITY ISSUES. A SURGICAL PROCEDURE WAS SUBSEQUENTLY PERFORMED, DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461024 ↗
• InjuryMar 17, 2026Mechanical Problem; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA PENILE PROSTHESIS, EXPERIENCED INCOMPLETE BENDING OF THE RIGHT CYLINDER AND WAS UNABLE TO USE THE DEVICE EFFECTIVELY. DURING THE SURGICAL PROCEDURE, IT WAS IDENTIFIED THAT A PORTION OF THE LATERAL RIGHT CORPORA WAS ABNORMALLY THIN, ALSO THE RIGHT CYLINDER MOVED OUT OF PLACE, CAUSING THE TACTRA CYLINDER TO BEND AT AN ABNORMAL ANGLE. A NEW TACTRA DEVICE WAS IMPLANTED ON THE RIGHT SIDE ONLY. ADDITIONALLY, THE PHYSICIAN REINFORCED THE THINNED SEGMENT OF THE CORPORA USING 3-0 PDS SUTURE. THE LEFT SIDE RETAINED THE ORIGINAL TACTRA IMPLANT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 24621452 ↗
• InjuryFeb 24, 2026Fracture; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S TACTRA PENILE PROTHESIS, EXHIBITED A BROKEN CYLINDER. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH WAS IDENTIFIED THAT THE BONE ANCHORS USED TO HOLD IT IN PLACE, TORE THROUGH THE SILICONE OF THE CYLINDER. THE TACTRA WAS REMOVED AND REPLACE WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434573 ↗
• InjuryJan 19, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA PENILE PROSTHESIS PRESENTED A PROBLEM WITH CONCEALABILITY WITH THE DEVICE. THE TACTRA DEVICE WAS EXPLANTED AND REPLACED WITH A BIGGER SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111937 ↗
• InjuryJan 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TACTRA DEVICE REVISION SURGERY FOR UNSPECIFIED REASONS. THE DEVICE WAS EXPLANTED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23985145 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS EROSION ON THE LEFT SIDE WHERE THE MALLEABLE PENILE PROSTHESIS (MPP) WAS LOCATED. THE PATIENT ALSO WANTED TO GO TO AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE, AND THE PHYSICIAN REMOVED AND REPLACED THE DEVICE THROUGH REPLACEMENT SURGERY, AND THERE WERE NO FURTHER SIGNS OR SYMPTOMS REPORTED.

  Patient problems: Erosion

  MAUDE report 23790540 ↗
• 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 23289874 ↗
• 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 23280316 ↗
• InjuryOct 10, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA IMPLANT EXPERIENCED PAIN DURING INTERCOURSE DUE TO SIGNIFICANT TORTUOUSNESS OF THE DEVICE TOWARD THE LEFT SIDE. UPON PHYSICAL EXAMINATION, THE PROSTHESIS DEMONSTRATED MARKED CURVATURE TO THE LEFT AND DID NOT REMAIN ERECT, EVEN WHEN MANUAL CONTRALATERAL SUPPORT WAS ATTEMPTED. THE DEVICE EXHIBITED MECHANICAL ISSUES BUT REMAINS IMPLANTED. A SURGICAL INTERVENTION IS PLANNED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 23266735 ↗
• InjurySep 19, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH A TACTRA IMPLANT EXPERIENCED PAIN IN THE PENILE AREA. DURING REVISION SURGERY, THE PHYSICIAN DETERMINED THAT THE ORIGINAL IMPLANT MAY HAVE BEEN PLACED TOO LONG. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 23101171 ↗
• InjurySep 10, 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 PENILE PROSTHESIS EXPERIENCED PAIN AND URINARY SYMPTOMS, INCLUDING HESITANCY AND POST-VOID DRIBBLING. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM (OR), AND A SCAN REVEALED A RETAINED REAR TIP FROM A PRIOR NON-BSC INFLATABLE IMPLANT. THE RIGHT MALLEABLE IMPLANT WAS EXPLANTED, AND A PERINEAL APPROACH WAS USED TO REMOVE THE RETAINED REAR TIP. A NEW TACTRA WAS IMPLANTED ON THE RIGHT SIDE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain; Urinary Retention

  MAUDE report 23022697 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS TACTRA WAS ASSOCIATED WITH EROSION. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE LEFT-SIDED TACTRA CYLINDER WAS REMOVED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion

  MAUDE report 22687007 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT CYLINDER OF THIS TACTRA MALLEABLE PENILE PROSTHESIS CAME OUT OF THE CORPORAL BODY. THE PATIENT CLAIMS THIS HAPPENED AFTER BEING ARRESTED AND SHOVED TO THE GROUND. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE BOTH CYLINDERS AND REPLACE IT WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE TACTRA IS NOT BEING RETURNED DUE TO CONTAMINATION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 22108369 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION NEAR THE CYLINDER AREA. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM FOR A TACTRA. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Erosion

  MAUDE report 22065810 ↗
• InjuryMay 20, 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 DEVELOPED AN INFECTION ON THE RIGHT SIDE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE RIGHT ROD AND ALLOW THE PATIENT TO HEAL. NO DEVICE ISSUES AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 22053712 ↗
• InjuryMay 14, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA DEVICE PRESENTED WITH CURVATURE OF THE PENILE SHAFT AND LOSS OF AXIAL RIGIDITY OF THE DEVICE; THEREFORE, A REPLACEMENT SURGERY WAS SCHEDULED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22019368 ↗
• MalfunctionMay 6, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS TACTRA PENILE PROSTHESIS STATES THAT THE DEVICE PRESENTED CROOKED, THE PATIENT IS UNABLE TO ALIGN IT, STATING THAT THE BASE APPEARS TO BE CRUSHED OR DEFORMED. THE PATIENT ALSO REPORTS THAT WHEN HE TRIES TO ADJUST IT, THE PROSTHESIS RETURNS TO ITS APPARENTLY INADEQUATE SHAPE. THE TACTRA REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970122 ↗
• InjuryApr 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT THIS TACTRA PENILE PROSTHESIS DURING USE IT BROKE IN TWO. THE TACTRA DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931318 ↗
• InjuryFeb 19, 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 PENILE PROSTHESIS EXPERIENCED PARAPHIMOSIS WITH MODERATE EDEMA OF THE FORESKIN; THEREFORE, THROUGH A NON-SURGICAL INTERVENTION, THE TISSUE WAS REPOSITIONED TO ITS NORMAL LOCATION AND THE EVENT WAS RESOLVED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information; Swelling/ Edema

  MAUDE report 21410483 ↗
• InjuryFeb 6, 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 PENILE PROSTHESIS EXPERIENCED IMPENDING EROSION OF RIGHT CORPORA BODY, THE TIP PROTRUDING THROUGH BELOW THE GLANS. THE TACTRA DEVICE WAS EXPLANTED AND REPLACED WITH AN IPP. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Erosion

  MAUDE report 21324723 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS TACTRA DEVICE WAS EXPLANTED DUE TO IMPEDING EROSION. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion

  MAUDE report 21286875 ↗
• InjuryNov 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS TACTRA MALLEABLE PENILE PROSTHESIS FOR UNSPECIFIED REASONS. ALL COMPONENTS OF THE EXISTING DEVICE WERE EXPLANTED AND REPLACED WITH A NEW INFLATABLE PENILE PROSTHESIS (IPP). NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621513 ↗
• MalfunctionOct 3, 2024Mechanical Problem; Migration; Mechanical Problem; Migration

  IT WAS REPORTED THAT THIS TACTRA PENILE PROSTHESIS EXHIBITED A MECHANICAL ISSUE. IT WAS NOTED THAT THE IMPLANT WAS ROTATING. THE PHYSICIAN TRIED TO RESOLVE THE ISSUE BUT WAS UNSUCCESSFUL. THE TACTRA IS CURRENTLY IMPLANTED, AND THE REPLACEMENT SURGERY IS ALREADY BOOKED. THE PHYSICIAN IS PLANNING TO IMPLANT A BIGGER TACTRA DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363579 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE AND REPLACE THE LEFT CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO EROSION. THE LEFT CYLINDER WAS EXPLANTED AND REPLACED WITH A MALLEABLE PROSTHESIS CYLINDER WHILE THE ORIGINAL RIGHT CYLINDER REMAINED IMPLANTED. A SECOND PROCEDURE WAS LATER PERFORMED WHERE BOTH THE INFLATABLE AND MALLEABLE CYLINDERS AND PUMP WERE REMOVED, REPLACED WITH NEW IPP COMPONENTS, AND CONNECTED TO THE EXISTING RESERVOIR. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 20177594 ↗