Titan Touch ES2924Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05708932768177), received between Apr 11, 2025 and Apr 22, 2026 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH GENESIS DUE TO MALFUNCTION OF THE PROSTHESIS AND LIKELY AN INFECTION. IT WAS NOTED THE MECHANISM TO DEFLATE THE PROSTHESIS ONLY WORKED AFTER SIGNIFICANT PRESSURE APPLIED AND LIKELY PURULENT FLUID (MOSTLY AROUND THE PUMP) FOUND DURING REVISION. HOWEVER, NO EXTERNAL SIGN OF INFECTION. THIS REPORT CAPTURES THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24955713 ↗
• InjuryApr 21, 2026Deflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH GENESIS DUE TO MALFUNCTION OF THE PROSTHESIS AND LIKELY AN INFECTION. IT WAS NOTED THE MECHANISM TO DEFLATE THE PROSTHESIS ONLY WORKED AFTER SIGNIFICANT PRESSURE APPLIED AND LIKELY PURULENT FLUID (MOSTLY AROUND THE PUMP) FOUND DURING REVISION. HOWEVER, NO EXTERNAL SIGN OF INFECTION. THIS REPORT CAPTURES THE DEFLATION PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943856 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN IMPLANT WAS REMOVED AND REPLACED BY A MALLEABLE (GENESIS) DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24808891 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A MALLEABLE DUE TO INFECTION. IT WAS NOTED THAT THE DEVICE WAS WORKING AS EXPECTED WITH NO MECHANICAL FAILURE.

  Patient problems: Unspecified Infection

  MAUDE report 24699274 ↗
• MalfunctionMar 5, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE PHYSICIAN DID NOT LIKE THE 14.5CM OF TUBING ON THE PRE-CONNECT DEVICE AS IT CAUSED AN EXCESS BUNDLE OF TUBING IN THE SCROTUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525627 ↗
• MalfunctionMar 3, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE TUBING OF THE PRE-CONNECT DEVICE WAS TOO LONG. NO MODIFICATION WERE MADE THOUGH AND THE DEVICE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496945 ↗
• InjuryFeb 24, 2026Insufficient Device Problem Information

  AN EXPLANTED DEVICE WAS RECEIVED FOR EVALUATION WITH NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430924 ↗
• MalfunctionFeb 24, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION THE SURGEON WOULD LOVE TO SEE THE TUBING OF THE 24 SCROTAL PRECONNECT SHORTENED. IT IS WAY TOO LONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429866 ↗
• MalfunctionFeb 23, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION THE DOCTOR USED THE NEW 24CM PRECONNECTED SCROTAL TOUCH IMPLANT. THE TUBING TO THE PUMP WAS TOO LONG SO HE HAD TO CUT SOME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414066 ↗
• MalfunctionFeb 19, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION TUBING IS TOO LONG. THE PHYSICIAN MADE IT WORK. HE WAS GOING TO TRIM TUBING BUT ENDED UP LEAVING IT ALONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24391114 ↗
• MalfunctionFeb 6, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT MEASURED 25CM (PERFECT FOR A 24CM PRECONNECT). THE SURGEON ASKED THE STAFF TO OPEN THE 24CM PRECONNECT TITAN TOUCH. UNFORTUNATELY, AN EXTRA 7 - 10 MINUTES WAS SPENT HAVING TO SHORTEN THE TUBING AND MAKE EXTRA CONNECTIONS. THE DEVICE WAS ULTIMATELY SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284188 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A GENESIS (PLACEHOLDER) DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24028413 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REPLACED DURING IMPLANT DUE TO A LEAKY CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827882 ↗
• MalfunctionOct 22, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE SURGEON EXPRESSED HIS DISDAIN FOR HAVING TO TRIM (CUSTOMIZE) THE TUBING LENGTH THAT WAS TOO LONG FOR THE PATIENT IN THE PRE-CONNECTED 24CM THAT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358233 ↗
• MalfunctionSep 12, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN TOUCH PENOSCROTAL 24CM PRECONNECT WAS BEING USED AND THE SURGEON MADE COMMENTS ABOUT HOW HE DOES NOT LIKE THIS IMPLANT BECAUSE THE TUBING LENGTH WAS TOO LONG (REDUNDANT). HE HAD TO FASHION THE TUBING (SHORTEN) TO MAKE IT WORK FOR THE PATIENT'S ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039546 ↗
• InjuryAug 4, 2025Malposition of Device; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A MISPLACED PUMP (HIGH RIDING PUMP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22706741 ↗
• MalfunctionApr 30, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE PHYSICIAN USED A NEW 24CM PRE-CONNECT AND UNFORTUNATELY THE TUBING WAS TOO LONG FOR THE PATIENT AND NEEDED TO BE TRIMMED. AFTER TRIMMING THE TUBING, THE PHYSICIAN REALIZED IT WAS TOO SHORT. THIS FACILITATED THE OPENING OF A FREE-STANDING PUMP WHICH WAS USED TO COMPLETE THE CASE. THERE WERE NO ISSUES WITH THE PATIENT AND THE CASE WAS COMPLETED WITH NO OTHER PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934372 ↗
• MalfunctionApr 11, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DOCTOR USED THE NEW 24 PRE-CONNECT DESIGN. HE FELT THE TUBING WAS TOO LONG; HOWEVER, DID NOT MODIFY (TRIM THE TUBING) DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21825727 ↗

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-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-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis

…and 3 more.