Titan® Titan Touch (REF EN2816)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05708932072519), received between Aug 6, 2021 and Apr 8, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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-1361-2023 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Device Appears to Trigger Rejection

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO EXTRUSION.

  Patient problems: Erosion

  MAUDE report 24815653 ↗
• InjuryAug 29, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING FRACTURE AND SUBSEQUENT FLUID LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22924104 ↗
• InjuryJul 7, 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 AND REPLACED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22412403 ↗
• InjuryMay 28, 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 INCORRECT SIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100104 ↗
• InjuryApr 3, 2025Device Appears to Trigger Rejection; Inadequacy of Device Shape and/or Size; Device Appears to Trigger Rejection; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO INCORRECT SIZE WHICH LED TO EROSION / EXTRUSION OF THE DEVICE.

  Patient problems: Erosion

  MAUDE report 21762501 ↗
• InjuryMar 31, 2025Malposition of Device; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED AS THE PATIENT HAD SST (GLANS PENIS DEFORMITY) AND THE TUBING WAS SUPERFICIAL.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21734154 ↗
• InjuryOct 10, 2024Inadequacy 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 SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417041 ↗
• InjuryMay 16, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP WAS REMOVED AND REPLACED DUE TO A TUBING LENGTH ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332494 ↗
• InjuryApr 23, 2024Malposition of Device; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE DUE TO PAIN AND POSSIBLE CROSSOVER.

  Patient problems: Pain

  MAUDE report 19165627 ↗
• InjuryJan 20, 2023Fluid/Blood Leak; Pumping Problem; Fluid/Blood Leak; Pumping Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A LEAK. IT WAS REPORTED THAT THE PUMP WOULD PUMP FOR A FEW PUMPS AND THEN IT WOULD DIMPLE AND COULD NOT PUMP ANYMORE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216419 ↗
• InjurySep 26, 2022Fracture; Fracture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING TEAR. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15487327 ↗
• InjuryDec 23, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REVISION DUE TO A HOLE IN A CYLINDER. THE RESERVOIR WAS RETAINED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13082795 ↗
• InjuryAug 6, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE AVAILABLE INFORMATION, A REVISION PROCEDURE WAS PERFORMED TO REPOSITION THE RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12290144 ↗

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-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; 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-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis

…and 2 more.