Titan® (REF EN8916)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05708932072632), received between Feb 14, 2019 and Jul 7, 2026 — classified as 15 injuries, 1 malfunction.

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

18 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25734585 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Erosion

  MAUDE report 25717752 ↗
• InjuryApr 15, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT REMOVED AND REPLACED DUE TO A TUBING FRACTURE AT THE CYLINDER EXIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886019 ↗
• InjuryAug 18, 2025Inflation Problem; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO IT NOT BEING SUFFICIENTLY RIGID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828399 ↗
• InjuryJun 20, 2025Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED TO REPOSITION THE PUMP AND CYLINDER AND INCREASE THE LENGTH OF THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298958 ↗
• InjuryJun 9, 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 AN INCORRECT SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170958 ↗
• InjuryDec 4, 2024Adverse 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 20844638 ↗
• InjuryNov 20, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO ONE SIDE OF THE IPP NOT INFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20739107 ↗
• InjuryJun 24, 2024Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A BREAK IN THE TUBING NEAR THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594362 ↗
• InjuryMar 27, 2024Crack; Crack

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A CRACKED/ SPLIT PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987315 ↗
• InjuryFeb 12, 2024Adverse 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 FLOPPY GLANS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686021 ↗
• InjuryJan 29, 2024Adverse 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 18597542 ↗
• MalfunctionJun 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED RETURN DUE TO AN UNKNOWN REASON. ON A VISUAL EXAMINATION OF THE DEVICE, AN ANEURYSM ON THE CYLINDER BLADDER WAS NOTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076509 ↗
• InjuryNov 7, 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. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 15743895 ↗
• InjuryOct 10, 2022Inadequacy of Device Shape and/or Size; Positioning Problem; Inadequacy of Device Shape and/or Size; Positioning Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO SIZE AND POSITION. THE DISTAL END OF THE DEVICE WAS AROUND 5 CM FROM THE GLANDS AND NOT SEATED PROPERLY AT THE DISTAL END OF THE PENIS. DUE TO THE PLACEMENT OF THE DEVICE, THE DEVICE WAS RENDERED NON-USABLE. THE DEVICE WAS FULLY FUNCTIONING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15571061 ↗
• InjuryFeb 14, 2019Break; Break

  ACCORDING TO THE AVAILABLE INFORMATION, PUMP WOULD NOT PUMP FLUID - SUSPECTED TUBING FRACTURE.

  Patient problems: No Information

  MAUDE report 8339664 ↗

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-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis

…and 3 more.