Titan ES2818Recalls & reported problems

Summary

The FDA's MAUDE database contains 222 adverse event reports that list this exact device (DI 05708932539128), received between Jul 24, 2017 and Jun 9, 2026 — classified as 192 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (42 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-1367-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 222 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 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 25449073 ↗
• InjuryMay 21, 2026Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN TOUCH IMPLANT WAS REMOVED AND REPLACED WITH A TITAN DUE TO IT NOT INFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241162 ↗
• InjuryMay 18, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210678 ↗
• InjuryMay 11, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A LEFT CYLINDER TUBING DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143178 ↗
• InjuryApr 16, 2026Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO PROXIMAL AND DISTAL CROSS OVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896614 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, DURING INITIAL IMPLANT, THE DEVICE WAS REMOVED DUE TO URETHRAL DAMAGE. RESERVOIR LEFT IN PATIENT.

  Patient problems: Perforation

  MAUDE report 24874434 ↗
• InjuryMar 18, 2026Inadequacy of Device Shape and/or Size

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634969 ↗
• InjuryMar 16, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605300 ↗
• MalfunctionFeb 23, 2026Pumping Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP IS NOT PUMPING ANY FLUID. IT IS NOTED THAT HITTING THE RELEASE BUTTON INFLATES THE PUMP BUT DOESN'T AFFECT CYLINDER INFLATION/DEFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421820 ↗
• InjuryFeb 23, 2026Fluid/Blood Leak; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE PUMP WOULDN'T FILL UP AND LEAKED. THE DEVICE WAS REMOVED AND REPLACED, AND A TUBING BREAK WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416645 ↗
• InjuryJan 20, 2026Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118114 ↗
• MalfunctionJan 8, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION DURING IMPLANT SURGERY, TRIED TO IMPLANT TITAN. IT WAS TOO TIGHT PROXIMALLY AND CYLINDERS WOULD NOT INFLATE. IMPLANT WAS REMOVED AND REPLACED WITH A DOWNSIZED NARROW BASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004827 ↗
• InjuryJan 6, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, A REVISION PROCEDURE WAS PERFORMED IN ORDER TO EXCHANGE THE PREVIOUS REAR TIP EXTENDERS (RTES) (1CM) WITH NEW RTES (2 CM) DUE TO INCORRECT SIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975241 ↗
• InjuryDec 30, 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 DUE TO THE CYLINDER BEING TOO SHORT AND THE PUMP BEING TOO HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928074 ↗
• InjuryDec 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED & REPLACED DUE TO A MALFUNCTION. THE ISSUE WAS NOT CLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23841691 ↗
• InjuryDec 4, 2025Disconnection; Fracture; Inflation Problem; Disconnection; Fracture; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE DEVICE NOT OPERATING [INFLATION ISSUE]. UPON INCISION AND MINIMAL DISSECTION, THE TUBING WAS EXPOSED, AND IT WAS APPARENT THAT THE TUBING HAD WITHDRAWN FROM THE CONNECTOR WITH SMALL REMNANTS OF IT REMAINING IN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720718 ↗
• InjuryNov 25, 2025Failure to Pump; Failure to Pump

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23650133 ↗
• InjuryNov 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A POSSIBLE TUBING LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604642 ↗
• InjuryNov 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED DUE TO AN UNSPECIFIED PENILE IMPLANT FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575851 ↗
• MalfunctionNov 11, 2025Inflation Problem; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT CYLINDERS WERE FLAT AFTER 20CC WAS PUT INTO SYSTEM. 10CC WAS PUT IN THEN ANOTHER 10CC WAS ADDED TO THE PUMP AND CHECKED FOR AIR IN THE PUMP BALL. THIS WAS DONE A FEW TIMES TO MAKE SURE ALL THE AIR WAS ALL OUT. AFTER INSERTION, THE DOCTOR SAID ONE CYLINDER WAS NOT INFLATING. THE CYLINDER WAS REMOVED FROM THE PATIENT AND TRIED AGAIN; IT DID NOT INFLATE. THE DOCTOR REMOVED THE OTHER CYLINDER (THAT WAS WORKING) AND PUT A SECOND IMPLANT CYLINDER AND PUMP IN WHICH WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526910 ↗
• InjurySep 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO FLUID LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095293 ↗
• InjuryAug 13, 2025Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO REQUIRING A SHORTER IMPLANT. IT WAS NOTED THIS PATIENT IS TRANSGENDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22799274 ↗
• InjuryAug 13, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794509 ↗
• InjuryAug 11, 2025Adverse 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 WITH A MALLEABLE (GENESIS) DUE TO SCROTAL SKIN EROSION AND INFECTION.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22778248 ↗
• InjuryAug 7, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO TUBING EXIT BREACH [FRACTURE].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737569 ↗

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-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; 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-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-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis

…and 2 more.