Titan ES8814Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05708932487160), received between Feb 12, 2018 and Mar 17, 2025 — classified as 6 injuries, 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A LOSS OF FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621391 ↗
• InjuryNov 2, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, PAIN FROM PUMP. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 12739797 ↗
• InjurySep 14, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, PATIENT HAD PAIN AT RESERVOIR LOCATION, THERE WAS A RESERVOIR HERNIATION. PATIENT'S TITAN ZERO DEGREE WAS EXPLANTED AND REPLACED WITH A GENESIS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hernia

  MAUDE report 12470752 ↗
• MalfunctionDec 7, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, FLUID LOSS - NO NOTICEABLE BREAK. THE DEVICE WAS REMOVED/REPLACED. 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: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 10958765 ↗
• InjurySep 15, 2020Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  ACCORDING TO THE AVAILABLE INFORMATION, WHILE IMPLANTING THE DEVICE THE PHYSICIAN HAD DIFFICULTY IMPLANTING BOTH CYLINDERS DUE TO SCAR TISSUE. HE TRIED VIGOROUSLY TO IMPLANT THE LEFT SIDE BUT COULD NOT IMPLANT THE CYLINDER. DURING REMOVAL OF THE LEFT CYLINDER THE REAR TIP EXTENDER DETACHED FROM THE LOCKING MECHANISM AND THE REAR TIP EXTENDER REMAINED IN THE PATIENT. THE CYLINDER ON THE RIGHT SIDE WAS ABLE TO BE IMPLANTED, SO THE PATIENT ONLY HAS ONE CYLINDER CURRENTLY IMPLANTED. AFTER CLOSURE BLOOD WAS NOTED COMING FROM THE URETHRA. THE PHYSICIAN SCOPED THE PATIENT BUT NO DAMAGE WAS NOTED TO THE BLADDER OR URETHRA. THE LEFT CYLINDER WAS DISCARDED AT SURGERY.

  Patient problems: Blood Loss; Foreign Body In Patient

  MAUDE report 10537632 ↗
• MalfunctionJun 15, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS PARTIALLY REMOVED AND REPLACED DUE TO SIZING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10155168 ↗
• InjuryOct 17, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT APPEARED TO BE MISSIZED, TOO SHORT. ANOTHER INFLATABLE DEVICE WAS IMPLANTED.

  Patient problems: No Information

  MAUDE report 9204926 ↗
• InjuryFeb 12, 2018Material Rupture; Torn Material; Material Rupture

  ACCORDING TO AVAILABLE INFORMATION, TITAN WAS EXPLANTED DUE TO TEAR IN PUMP.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7265547 ↗

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-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; 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-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis

…and 3 more.