Titan® Titan Touch (REF EN2818)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05708932072526), received between May 15, 2018 and Feb 11, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

17 other recalls cover devices cleared under the same FDA submission (P000006); they may or may not involve this specific model.

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.

Recalls naming this device

1. Mar 1, 2023Open, Classified

   A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.

   Z-1362-2023 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO BROKEN TUBING NEAR PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314953 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED DUE TO EROSION. ONE CYLINDER WAS EXPLANTED, AND THE OTHER WAS PLUGGED.

  Patient problems: Erosion

  MAUDE report 23877211 ↗
• InjuryDec 11, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING FRACTURE BETWEEN THE PUMP AND CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778994 ↗
• InjuryNov 10, 2025Unintended Deflation; Unintended Deflation

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED AS ONCE IT WAS FULLY INFLATED, THE IMPLANT WOULD START TO SLOWLY DEFLATE. RESERVOIR WAS LEFT IMPLANTED AND A WHOLE NEW IPP SYSTEM WAS RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512172 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO SST SYNDROME (FLOPPY GLANS).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21657639 ↗
• InjuryMar 13, 2025Malposition of Device; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE PUMP NEEDING TO BE REPOSITIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599550 ↗
• InjuryJan 7, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE PATIENT NEEDING A LARGER SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096632 ↗
• MalfunctionAug 8, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION THE REGULAR SIZED TITAN WOULDN'T SEAT PROXIMALLY. DURING THE SAME SURGERY, THE SURGEON REMOVED IT AND IMPLANTED A NARROW BASE INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938350 ↗
• InjuryMar 6, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO STICKY PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848905 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT WAS REMOVED AND REPLACED DUE TO INFECTION AND EROSION.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 18140943 ↗
• InjuryMay 12, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO SIZE. THE NARROW CYLINDERS WERE REPLACED WITH STANDARD CYLINDERS. THE RESERVOIR WAS RETAINED AND REUSED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16917302 ↗
• InjuryMar 30, 2023Positioning Problem; Positioning Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO POSITIONING. THE DEVICE WAS MISPLACED. THE REPLACEMENT REAR TIP EXTENDER ON THE LEFT CYLINDER WAS CUT 1/2 CM. A 75 CC RESERVOIR WAS IMPLANTED AND FILLED TO 60 CC. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16643552 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE IMPLANTED. PATIENT WAS EXPLANTED OVER A YEAR AGO AND WAS EXTREMELY FIBROTIC. A URETHRAL INJURY OCCURRED DURING SERIAL DILATION AND THE DEVICE WAS NOT ABLE TO BE IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 15676543 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO INFECTION. A DEVICE FROM ANOTHER MANUFACTURER WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15385438 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT EXPERIENCED AN INFECTION. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763044 ↗
• InjuryMay 27, 2021Pumping Problem; Pumping Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO A COLLAPSED PUMP. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897836 ↗
• InjuryMay 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, SUSPECTED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7516023 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000006. One submission often covers many models, so check the product and lot details in each record.

• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis

…and 2 more.