Titan EN8814Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708932532693), received between Jun 22, 2021 and Aug 11, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770611 ↗
• InjuryJun 22, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT THE IMPLANT WOULD ALSO ONLY PARTIALLY DEFLATE. THE PUMP WAS MALFUNCTIONING. SEVERE FIBROSIS WAS ALSO NOTED.

  Patient problems: Fibrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12043386 ↗

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-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; 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-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; 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-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; 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.