TACTRARecalls & reported problems across all models

We found 3 models of TACTRA by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 260 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2019 and Aug 31, 2026 — classified as 240 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (53 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TACTRA problems

TACTRA models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TACTRA 720081-01

  PROSTHESIS, PENILE
  150 reports
• TACTRA 720080-01

  PROSTHESIS, PENILE
  61 reports
• TACTRA 720082-01

  PROSTHESIS, PENILE
  49 reports

Recent TACTRA adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryAug 20, 2026Inadequacy of Device Shape and/or Size

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

  MAUDE report 50360037 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗

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