Titan® (REF EN8818)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 05708932072601), received between Jul 17, 2018 and May 12, 2026 — classified as 35 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Erosion

  MAUDE report 25148675 ↗
• MalfunctionApr 21, 2026Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, PATIENT CANNOT GET THE IMPLANT AS HARD AS THEY HAD HOPED TO. ADDITIONALLY, IT SEEMS THEY HAVE LOST SOME LENGTH AS THEY WERE TOLD MIGHT HAPPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939306 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED DUE TO SIGNIFICANT CURVATURE CAUSING PAIN WITH INFLATION. DURING THE REVISION, ONLY THE LEFT SIDE SINGLE CYLINDER WAS ABLE TO BE PLACED. THE PHYSICIAN WAS UNABLE TO PLACE ON RIGHT SIDE. THE PREVIOUSLY IMPLANTED RESERVOIR WAS RETAINED AND FUNCTIONAL FOR USE WITH NEWLY IMPLANTED CYLINDER/PUMP.

  Patient problems: Deformity/ Disfigurement; Pain

  MAUDE report 24863773 ↗
• InjuryMar 30, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A TITAN TOUCH DUE TO A TUBING BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735313 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO URETHRA EROSION.

  Patient problems: Erosion

  MAUDE report 24394976 ↗
• InjuryFeb 6, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE IMPLANT BEING SLIGHTLY UNDERSIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282842 ↗
• InjuryFeb 6, 2026Inflation Problem; Deformation Due to Compressive Stress

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO TUBING KINK. THE IMPLANT WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282783 ↗
• InjuryDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED & REPLACED DUE TO A TUBING LEAK LEADING FROM THE CYLINDER ENTRANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682667 ↗
• InjuryNov 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 IT BEING TOO SHORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509579 ↗
• InjuryAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PUMP LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793997 ↗
• InjuryMay 27, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT CYLINDER WAS REMOVED AND REPLACED AS THE CYLINDER SIZE NEEDED TO BE EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089071 ↗
• InjuryApr 24, 2025Collapse; Collapse

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A COLLAPSED PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21904355 ↗
• InjuryApr 22, 2025Malposition of Device; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REPOSITIONED AS THE CYLINDER WAS CROSSED OVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882211 ↗
• MalfunctionFeb 25, 2025Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION, DURING INITIAL IMPLANT OF THE CYLINDER, THE DOCTOR PERFORMED MODELING. AFTER A FEW ATTEMPTS AND A TEST INFLATE THE IMPLANT DIDN'T WORK. DOCTOR CLAIMED ONE OF THE CYLINDERS HAD AN ANEURYSM IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463355 ↗
• InjuryJan 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 THE BLADDER NEEDING TO BE REPAIRED.

  Patient problems: Perforation

  MAUDE report 21097505 ↗
• InjuryNov 12, 2024Malposition of Device; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE RIGHT DISTAL CYLINDER WAS RE-POSITIONED. NO REMOVAL OR REPLACEMENT OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664643 ↗
• InjuryOct 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20528787 ↗
• InjurySep 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A LEAK IN THE TUBING COMING FROM THE CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241515 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 20125996 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS A DISTAL HERNIA AND DISTAL FIXATION WAS PERFORMED. THE DEVICE WAS NOT EXPLANTED.

  Patient problems: Hernia

  MAUDE report 19605879 ↗
• InjuryMay 24, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED AS THE PATIENT WAS UNHAPPY WITH THE PLACEMENT OF THE CYLINDERS. THE CYLINDERS WERE NOT PLACED MID GLANDS AND WERE UNEVEN. THE 18 CM NARROW BASE + 1CM REAR TIP EXTENDER WAS REPLACED WITH AN 18 CM NARROW + 3CM REAR TIP EXTENDERS. THIS WAS A MUCH BETTER OUTCOME FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391620 ↗
• InjuryMay 20, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A SIZING ISSUE. A NARROW-BASED DEVICE WAS REPLACED WITH A STANDARD BASE TITAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350753 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A CORPORAL HERNIA AND THE NEED FOR A CORPOROPLASTY ON THE LEFT SIDE.

  Patient problems: Hernia

  MAUDE report 19214383 ↗
• InjuryMar 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896873 ↗
• InjuryDec 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT WAS EXPLANTED AND REPLACED DUE TO A LEAK IN THE TUBING. THE DEVICE LEAKS IN THE SPOT WHERE THE TUBING CONNECTS WITH THE RESERVOIR JUST DISTAL TO THE LOCKOUT VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18348066 ↗

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-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; 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-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis

…and 3 more.