Titan ES2914Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05708932539166), received between Jul 25, 2017 and Dec 10, 2025 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO BROKEN TUBING A FEW INCHES FROM THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768221 ↗
• InjuryNov 18, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING BREAK AT THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581709 ↗
• InjuryNov 20, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Erosion

  MAUDE report 20734686 ↗
• InjuryJan 15, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION WHEN ATTEMPTING TO INFLATE THE DEVICE IT RETURNED TO FLACCID STATE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510646 ↗
• InjuryNov 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING LEAK NEAR THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107066 ↗
• MalfunctionNov 8, 2023Material Deformation; Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION THIS WAS A VIRGIN CASE AND NOT A REVISION. AFTER THE IMPLANT WAS PLACED IN THE CORPORAL BODIES, IT WAS INFLATED IT AND NOTICED ONE OF THE CYLINDERS HAD AN ANEURYSM. AFTER REMOVAL OUT OF THE BODY IT WAS INFLATED AGAIN OUTSIDE OF THE BODY AND THE ANEURYSM CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091491 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO INFECTION. THERE WAS AN INFECTION AT THE PUMP SITE. A MALLEABLE DEVICE WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17000186 ↗
• InjuryApr 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO INFECTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16792549 ↗
• InjuryMar 28, 2023Fracture; Fracture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625334 ↗
• InjuryAug 15, 2022Fracture; Fracture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. IT WAS NOTED THE BREAK WAS JUST ABOVE THE REINFORCED PORTION OF THE RIGHT CYLINDER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224477 ↗
• InjuryAug 4, 2020Mechanical Problem; Mechanical Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10362682 ↗
• InjuryDec 18, 2019Pumping Problem; Pumping Problem

  ACCORDING TO THE AVAILABLE INFORMATION, NO FLUID IN PUMP, PUMP WAS NOT CYCLING FLUID AT ALL. ANOTHER INFLATABLE DEVICE WAS IMPLANTED.

  Patient problems: No Information

  MAUDE report 9490856 ↗
• InjuryJul 23, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS ONLY A REVISION SURGERY TO GAIN EXTRA TUBING LENGTH FOR THIS PARTICULAR PATIENT WHO FELT THE PUMP SAT A BIT HIGH IN THE SCROTUM FOR HIS COMFORT. THERE WAS NO FAULT IN THE EXISTING PUMP OR DEVICE.

  Patient problems: Discomfort

  MAUDE report 8818378 ↗
• InjuryJun 5, 2019Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE TUBING FRACTURED. THE COIL WAS COMPLETELY HANGING OUT OF THE TUBING.

  Patient problems: No Information

  MAUDE report 8670576 ↗
• InjuryMay 31, 2019Mechanical Jam; Pumping Problem; Mechanical Jam; Pumping Problem

  ACCORDING TO THE AVAILABLE INFORMATION, HARD PUMP.

  Patient problems: No Information

  MAUDE report 8660651 ↗
• InjuryJul 25, 2017Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, INFECTION - SCROTAL AT PUMP.

  Patient problems: Unspecified Infection

  MAUDE report 6741849 ↗

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-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; 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-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.