Titan ES2814Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05708932539104), received between Jan 30, 2020 and Jun 19, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2026Off-Label Use; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INCORRECT SIZING (TOO SHORT). GENDER AFFIRMATION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563327 ↗
• InjurySep 24, 2025Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information

  ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THE DEVICE WAS EXPLANTED DUE TO INFECTION AND EROSION. IT WAS A GENDER AFFIRMATION CASE.

  Patient problems: Erosion; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 23134012 ↗
• InjuryJul 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE CORPOROTOMY BEING OPEN WITH THE CYLINDER EXPOSED [EROSION/ EXTRUSIO].

  Patient problems: Erosion

  MAUDE report 22395441 ↗
• InjuryJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THERE BEING NO FLUID IN THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337153 ↗
• InjuryJul 8, 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 AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19693039 ↗
• InjuryNov 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A MALFUNCTION OF THE PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18113674 ↗
• InjuryMay 25, 2022Inflation Problem; Pumping Problem; Inflation Problem; Pumping Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO AN INFLATION ISSUE (FAILURE TO PUMP). NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498244 ↗
• InjuryNov 29, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, PATIENT WANTED TO SWITCH TO A MALLEABLE. ALPHA I WAS EXPLANTED AND REPLACED WITH A GENESIS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888696 ↗
• InjuryNov 19, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, PATIENT HAD EROSION. DEVICE WAS EXPLANTED AND WAS NOT REPLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Skin Erosion

  MAUDE report 12841349 ↗
• InjuryNov 12, 2021Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON (B)(6) 2017 AND REVISED ON (B)(6) 2021 DUE TO A TUBING FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801681 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE TITAN TOUCH WAS IMPLANTED AND REVISED ON (B)(6) 2021 DUE TO AN INFECTION IN THE PATIENT¿S SCROTUM.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 12763815 ↗
• InjuryOct 30, 2021Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS REVISED ON (B)(6) 2021 DUE TO A DEFECT ON THE TUBING FROM THE PUMP TO THE LEFT CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725042 ↗
• InjuryDec 4, 2020Missing Information; Missing Information

  ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, INFECTION. DEVICE REMOVED AND REPLACED WITH A MALLEABLE. THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED.

  Patient problems: Unspecified Infection

  MAUDE report 10946806 ↗
• InjuryJan 30, 2020Inadequacy of Device Shape and/or Size; Positioning Problem; Inadequacy of Device Shape and/or Size; Positioning Problem

  ADDITIONAL INFORMATION RECEIVED STATED, SST DEFORMITY WITH IMPLANT TIP BEHIND GLANS, RESERVOIR IN GOOD POSITION. POSITIONING RESULTED IN PAIN, MALPOSITION. THE EXPLANTED DEVICE WAS TO SMALL AND WAS NOT SITTING PROPERLY. THE DOCTOR REMEASURED AND INSERTED A NEW DEVICE.

  Patient problems: Deformity/ Disfigurement; No Information; Pain

  MAUDE report 9649510 ↗

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-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; 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-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; 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-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; 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-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis

…and 3 more.