Titan E17924Recalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 05708932487429), received between Jul 23, 2017 and Jun 26, 2026 — classified as 119 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (20 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 25 most recent of 132 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Migration

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE PUMP RIDING TOO HIGH IN THE SCROTUM FROM PREVIOUS PLACEMENT. THE PATIENT HAD A PERFORATION PROXIMALLY WHICH LED THE IMPLANT TO MIGRATE POSTERIORLY WHICH IN TURN PULLED THE PUMP INTO AN UNCOMFORTABLE POSITION IN THE PATIENT'S SCROTUM. THE SIZING OF THE IMPLANT WAS CHANGED FROM 24 CM TO 20 CM DUE TO THIS PATIENT'S POSTERIOR PREPARATION THAT WAS FIXED WITH A SUTURE SLING PROCEDURE.

  Patient problems: Discomfort; Perforation

  MAUDE report 25643372 ↗
• InjuryJun 2, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING FRACTURE ON THE RIGHT SIDE LEADING FROM PUMP TO CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25365523 ↗
• InjuryMay 19, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INCORRECT SIZING (TOO SHORT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219153 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN TOUCH WAS REMOVED AND REPLACED WITH A GENESIS DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24967516 ↗
• InjuryApr 23, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE RIGHT 24CM CYLINDER WAS REMOVED AND REPLACED WITH A 22 CM [SIZING ISSUE].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966449 ↗
• InjuryApr 20, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925066 ↗
• InjuryApr 16, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO OVERSIZED CYLINDERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899648 ↗
• InjuryApr 14, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874346 ↗
• InjuryApr 6, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP WAS REMOVED AND REPLACED DUE TO A TUBING BREAK AT CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789638 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED DUE TO MULTIPLE ABSCESSES (INFECTION).

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 24474688 ↗
• InjuryFeb 26, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461676 ↗
• InjuryFeb 6, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO REMOVED AND REPLACED DUE TO MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278575 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED WITH A GENESIS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24246130 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A GENESIS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24201857 ↗
• MalfunctionJan 20, 2026Material Twisted/Bent

  ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT REPORTS DISCOMFORT AND WORSENING PAIN FROM POSSIBLE TWISTED TUBING. THE PATIENT HAS ALSO NOTICED BULGING IN HIS SKIN IN TWO LOCATIONS.

  Patient problems: Discomfort; Pain

  MAUDE report 24118411 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO EROSION.

  Patient problems: Erosion

  MAUDE report 24042192 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO EROSION.

  Patient problems: Erosion

  MAUDE report 23950790 ↗
• InjuryDec 23, 2025Fracture; Inflation Problem; Physical Resistance/Sticking; Fracture; Inflation Problem; Physical Resistance/Sticking

  ACCORDING TO THE AVAILABLE INFORMATION, IT WAS ADDITIONALLY REPORTED THAT THE IMPLANT WAS REMOVED AND REPLACED DUE TO TUBING BREAK BETWEEN RESERVOIR AND CYLINDER/PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876971 ↗
• InjuryDec 8, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION IT WAS REPORTED THERE WAS A LEAK ON THE DEVICE. THE PHYSICIAN STATED THAT THE TUBING THAT CONNECTS TO THE PUMP IS LEAKING OUT SINCE AROUND (B)(6)2025. NO INTERVENTION HAS BEEN TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750807 ↗
• InjuryDec 2, 2025Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO OVERSIZED AND DISPLACED CYLINDERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697800 ↗
• InjuryNov 18, 2025Inflation Problem; Connection Problem; Inflation Problem; Connection Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO IT NOT INFLATING. THERE WAS FOUND TO BE A DEFECTIVE CONNECTION BETWEEN THE PUMP AND THE RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584017 ↗
• MalfunctionSep 15, 2025Material Deformation; Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT IS CONCERNED ABOUT THE IMPLANT ¿ACCORDIONING¿ IN THE FLACCID STATE. WHEN FULLY INFLATED, THE DEVICE HAS SUFFICIENT LENGTH AND GIRTH, BUT WHEN DEFLATED, IT SHRINKS IN LENGTH AND BUCKLES/PUCKERS. IN ADDITION, HE NOTICED A BULGE AT THE BASE OF THE IMPLANT WHEN INFLATED, WHERE IT IS WIDER THAN THE REST OF THE DEVICE. THIS HAS BEEN ¿GETTING WORSE OVER THE COURSE OF A YEAR¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058662 ↗
• InjurySep 15, 2025Air/Gas in Device; Air/Gas in Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THERE BEING AIR IN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058534 ↗
• InjurySep 15, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING FRACTURE FROM THE PUMP TO THE CYLINDERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052522 ↗
• InjurySep 9, 2025Migration; Migration

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT HERNIATED [MIGRATED] OUT OF THE CORPORA. IT WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009703 ↗

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-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• 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-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; 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-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis

…and 3 more.