Titan® (REF EN8816)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05708932072595), received between Aug 15, 2019 and Dec 22, 2025 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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-1365-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED & REPLACED DUE TO BROKEN TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865437 ↗
• InjuryNov 11, 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 IMPENDING EROSION.

  Patient problems: Erosion

  MAUDE report 23526379 ↗
• InjuryOct 20, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A CYLINDER FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23342626 ↗
• InjuryJul 10, 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 22474228 ↗
• InjuryJul 3, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, A REVISION SURGERY WAS PERFORMED TO IMPLANT REAR TIP EXTENDERS DUE TO INCORRECT SIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22399196 ↗
• InjuryApr 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937009 ↗
• InjuryJan 30, 2024Migration; Migration

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO RESERVOIR MIGRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606401 ↗
• MalfunctionNov 14, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT WAS IMPLANTED WITH RIGHT CORPORA 16CM AND LEFT CORPORA 18CM DUE TO THE ORIGINAL CYLINDER IN THE LEFT CORPORA BEING PUNCTURED BY A SUTURE. THEREFORE, IT HAD TO BE REPLACED WITH THE 18CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133025 ↗
• InjuryJun 1, 2023Failure to Pump; Failure to Pump

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. THE TUBING BROKE 1 INCH FROM THE PUMP WHICH CAUSED A PUMP FAILURE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038906 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Hematoma

  MAUDE report 16272061 ↗
• InjuryOct 26, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO EROSION. THE RESERVOIR WAS RETAINED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 15672739 ↗
• InjuryApr 20, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REVISION DUE TO A MISSED PROXIMAL PERFORATION ON THE RIGHT SIDE. IT WAS NOTED THE CYLINDERS WERE NOT CHANGED TO ADD THE REAR TIP EXTENDERS DURING THE REVISION AND A REAR TIP EXTENDER SLING WAS USED AT THE BASE OF THE CYLINDER. ONLY THE ASSEMBLY KIT WAS USED IN THE REVISION.

  Patient problems: Perforation

  MAUDE report 14159870 ↗
• InjuryApr 13, 2022Positioning Problem; Insufficient Device Problem Information; Positioning Problem; Insufficient Device Problem Information

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO PATIENT REQUESTING LONGER/LARGER CYLINDERS AS WELL AS AN UNSPECIFIED MALFUNCTION AND POOR PUMP POSITIONING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14103541 ↗
• MalfunctionJul 10, 2020Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP BULB ONLY WAS EXCHANGED DUE TO PUMP FAILURE. (SEPARATION OF PUMP BULB.)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10260762 ↗
• InjuryAug 15, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  THIS EVENT WAS FIRST OBSERVED IN (B)(6) 2019.

  Patient problems: No Information

  MAUDE report 8898447 ↗

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-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; 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-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; 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 2 more.