Titan 90-9818INCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05708932322584), received between Dec 5, 2019 and Jun 7, 2023 — classified as 4 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2023Failure to Pump; Failure to Pump

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO NOT PUMPING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084080 ↗
• InjuryFeb 8, 2022Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED AS THE IMPLANT WAS UNDERSIZED AND IMPROPERLY PLACED. THE NEW IMPLANT HAD TO BE RE-ROUTED IN ORDER TO BE PLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13479511 ↗
• InjuryAug 5, 2021Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE DID NOT WORK. THE DEVICE WAS EXPLANTED AND REPLACED. THE EXPLANTED DEVICE WAS DISPOSED OF. IT WAS BELIEVED TO BE A LEAK; HOWEVER, THERE WERE NO VISIBLE FRACTURES OR SEPARATIONS IN THE DEVICE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284488 ↗
• MalfunctionJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO AVAILABLE INFORMATION, THE PATIENT WITH THIS DEVICE EXPERIENCED PENDING EROSION AND MILD GLANS HYPERMOBILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242706 ↗
• MalfunctionJul 28, 2021Adverse Event Without Identified Device or Use Problem

  ACCORDING TO AVAILABLE INFORMATION, THE PATIENT WITH THIS DEVICE EXPERIENCED URETHRAL PERFORATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 12239180 ↗
• InjuryDec 5, 2019Fluid/Blood Leak; Inflation Problem; Leak/Splash; Fluid/Blood Leak; Inflation Problem; Leak/Splash

  ACCORDING TO THE AVAILABLE INFORMATION, A MALFUNCTION WAS REPORTED WHERE THE INFLATABLE PENILE PROSTHESIS WOULD NOT INFLATE AND THERE WAS A LOSS OF FLUID. THE DEVICE WAS REPLACED WITH ANOTHER INFLATABLE PENILE PROSTHESIS. THIS EVENT WAS OBSERVED IN (B)(6) 2019.

  Patient problems: No Information

  MAUDE report 9417588 ↗

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-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; 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-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; 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-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis

…and 3 more.