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Titan ENR814Recalls & reported problems

Coloplast A/S · Infrapubic OTR Zero Degree Angle Cylinder Set with Pump - Narrow · Class 3 · Implant

All models of Titan (62)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932532730), received between Dec 29, 2017 and Dec 29, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 29, 2017Fluid/Blood Leak

    ACCORDING TO THE AVAILABLE INFORMATION, TUBING LEAK CLEAR.

    Patient problems: No Information

    MAUDE report 7155216 ↗

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-1367-2023 · Mar 1, 2023 · Open, Classified
    Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
  • Z-1371-2023 · Mar 1, 2023 · Open, Classified
    Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; 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-1362-2023 · Mar 1, 2023 · Open, Classified
    Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
  • Z-1368-2023 · Mar 1, 2023 · Open, Classified
    Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; 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-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-1363-2023 · Mar 1, 2023 · Open, Classified
    Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; 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-1369-2023 · Mar 1, 2023 · Open, Classified
    Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis

…and 3 more.

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Sources and updates

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