Titan ESR816Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05708932487528), received between Jul 24, 2017 and Dec 23, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Pumping Problem; Pumping Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NOT PUMPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881929 ↗
• InjuryMay 9, 2025Inflation Problem; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED AS THE PROSTHESIS WAS NOT INFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996302 ↗
• InjuryMar 20, 2023Fracture; Fracture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. THERE WAS A BREAK AT THE BLACK TUBE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572288 ↗
• InjuryMar 8, 2022Fracture; Material Protrusion/Extrusion; Fracture; Material Protrusion/Extrusion

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO TUBING EXTRUDING FROM THE SCROTUM. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690208 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, INFECTION IN SCROTUM. DEVICE WAS EXPLANTED AND REPLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 12763822 ↗
• MalfunctionAug 9, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO AVAILABLE INFORMATION THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE - REASON UNKNOWN. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12295205 ↗
• InjuryNov 21, 2019Break; Inflation Problem; Break; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, A BREAK IN TUBING WAS REPORTED. THE DEVICE COULD NOT BE PUMPED. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Information

  MAUDE report 9356068 ↗
• InjuryAug 14, 2019Break; Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE TUBING BROKE AT THE CYLINDER JUNCTION.

  Patient problems: No Information

  MAUDE report 8895243 ↗
• InjuryMar 19, 2018Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, DOWN SIZE OF RTE ON LEFT SIDE WITH CYLINDER EXCHANGE AS WELL.

  Patient problems: Failure of Implant

  MAUDE report 7348510 ↗
• InjuryAug 16, 2017Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, AN ANEURYSM OF CYLINDER THROUGH CORPOROTOMY WAS REPORTED.

  Patient problems: Aneurysm

  MAUDE report 6796755 ↗
• InjuryJul 24, 2017Device Operates Differently Than Expected

  ACCORDING TO THE AVAILABLE INFORMATION, CYLINDER CROSSOVER.

  Patient problems: No Information

  MAUDE report 6738003 ↗

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-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; 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-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; 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-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis

…and 3 more.