Titan 519150Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05701780276979), received between Jul 24, 2024 and May 21, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Connection Problem

  ACCORDING TO THE AVAILABLE INFORMATION, SOME OF THE CONNECTORS INCLUDED IN THE ASSEMBLY KIT SEEMED TO HAVE EXTRA PLASTIC ON THE INSIDE WHICH MADE IT DIFFICULT OR IMPOSSIBLE TO THREAD DOWN THE BLACK TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241817 ↗
• MalfunctionDec 23, 2025Connection Problem; Connection Problem

  ACCORDING TO THE AVAILABLE INFORMATION, DURING A CASE, THE CONNECTOR WAS DAMAGED. IT IS UNCLEAR IF IT WAS CAUSED BY THE DOCTOR USING THE CUFF BACKWARDS WHEN HE TRIED TO CONNECT, BUT THE CENTER PIECE OF CONNECTER WAS SMASHED. ANOTHER CONNECTOR WAS USED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881618 ↗
• MalfunctionMar 21, 2025Inaccurate Information; Inaccurate Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT STICKERS INCLUDED IN THE ACCESSORY KIT DID NOT MATCH THE PACKAGING (RETAIL BOX AND POUCH).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668287 ↗
• MalfunctionJan 3, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, DURING AN IMPLANT PROCEDURE, THE TUBING CONNECTOR FAILED. AS THE DOCTOR APPLIED PRESSURE WHILE CONNECTING TUBING BETWEEN THE RESERVOIR AND CYLINDER ASSEMBLY, THE CONNECTOR COLLAPSED. THE DOCTOR WAS ABLE TO SALVAGE THE BROKEN CONNECTOR IN ONE PIECE. HE WAS THEN ABLE TO USE A SECOND CONNECTOR AND COMPLETE THE CASE WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072672 ↗
• MalfunctionDec 2, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE CRIMPING TOOL DAMAGED THE CENTERPIECE CONNECTOR. ANOTHER CONNECTOR WAS USED TO SUCCESSFULLY COMPLETE THE IMPLANT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819344 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, DURING AN ATTEMPT TO IMPLANT THE TITAN, THERE WAS A URETHRAL PERFORATION SO THE CASE WAS ABORTED.

  Patient problems: Perforation

  MAUDE report 20781039 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, DURING SURGERY TO PLACE A VIRGIN IMPLANT FOR THE PATIENT, THE PATIENT'S URETHRA SUSTAINED INJURIES WHILE THE STAY SUTURES WERE BEING PLACED. THE CASE WAS ABORTED DUE TO THE URETHRAL DAMAGE.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 20389763 ↗
• MalfunctionJul 24, 2024Contamination; Contamination

  ACCORDING TO THE AVAILABLE INFORMATION, A PIECE OF PAPER WAS FOUND IN THE INNER TRAY OF THE ASSEMBLY KIT. THE PRODUCT WAS USED FOR THE CASE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822399 ↗

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-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; 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-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; 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-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-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis

…and 3 more.