Titan 519300 (UDI 05708932527354)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05708932527354), received between May 10, 2019 and Sep 19, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Unsealed Device Packaging; Unsealed Device Packaging

  ACCORDING TO THE AVAILABLE INFORMATION, ON OPENING A SET OF THE NARROW RTE'S [REAR TIP EXTENDERS], IT WAS IDENTIFIED THAT THE INNER PACKAGING [TRAY] WAS COMPROMISED [NOT SEALED]. IT WAS REPORTED THAT ALL EXTERNAL SEALS AND THE BOX ITSELF WERE INTACT BEFORE OPENING. ANOTHER SIZE OF DEVICE (18CM) WAS USED INSTEAD OF THE INITIAL INTENDED DEVICE (16CM WITH REAR TIP EXTENDERS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099395 ↗
• InjuryApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO DETACHMENT. THE REAR TIP CAME OFF IN THE CORPORA DURING DEVICE IMPLANT. THE CYLINDERS WERE NOT ABLE TO BE IMPLANTED. THE REAR TIP NEEDS TO BE RETRIEVED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16804685 ↗
• InjuryMay 10, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, REPLACED LEFT 1 CM REAR TIP EXTENDER WITH 1.5 CM REAR TIP EXTENDER

  Patient problems: No Information

  MAUDE report 8601399 ↗
• InjuryMay 10, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, NO MALFUNCTION NOTED. CORRECTION OF SIZING.

  Patient problems: No Information

  MAUDE report 8601392 ↗

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-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; 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-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; 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-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-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis

…and 3 more.