Titan ES2916Recalls & reported problems

Summary

The FDA's MAUDE database contains 178 adverse event reports that list this exact device (DI 05708932539173), received between Jul 24, 2017 and Jun 11, 2026 — classified as 153 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (28 reports).

1 FDA recall record name this device's identifier, 1 still open.

17 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.

Recalls naming this device

1. Mar 1, 2023Open, Classified

   A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.

   Z-1369-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 178 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP WAS REMOVED AND REPLACED DUE TO PATIENT'S PUMP WAS RIDING UP, NEEDED MORE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477369 ↗
• InjuryApr 21, 2026Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938167 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak; Air/Gas in Device

  ACCORDING TO THE AVAILABLE INFORMATION, DURING INTRAOPERATIVE PREPARATION OF A 16 CM TOUCH SCROTAL DEVICE, A PERSISTENT AIR INFILTRATION ISSUE WAS OBSERVED. DESPITE MULTIPLE PREPARATION ATTEMPTS, AIR CONTINUED TO RETURN TO THE PUMP MECHANISM. THE DEVICE WAS DETERMINED TO HAVE A SUSPECTED MANUFACTURING DEFECT [LEAK] AND WAS REPLACED WITH A NEW UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322743 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23555139 ↗
• InjuryOct 31, 2025Material Frayed; Material Frayed

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO FRAYED TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438983 ↗
• InjuryOct 24, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO IT BEING TOO SHORT AND PATIENT PREFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384491 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22979087 ↗
• InjuryAug 19, 2025Pumping Problem; Pumping Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN PUMP DIFFICULTY. REPLACED BOTH PUMP AND CYLINDERS AND CONNECTED TO EXISTING RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839473 ↗
• InjuryAug 11, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A BREAK [FRACTURE] IN THE CYLINDER TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770759 ↗
• InjuryJul 15, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO DEFECTIVE TUBING [FRACTURED TUBING].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22510332 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22463611 ↗
• InjuryMay 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED FOR AN UNKNOWN REASON. DETAILS SURROUNDING THE EXPLANT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080824 ↗
• InjuryMay 13, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A BREAK (FRACTURE) IN THE TUBING WHERE THE TUBING MEETS THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22012805 ↗
• InjuryMay 7, 2025Inflation Problem; Material Perforation; Inflation Problem; Material Perforation

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO NOT PUMPING UP. THERE WAS A POSSIBLE SUTURE PERF IN THE LEFT CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976599 ↗
• MalfunctionMay 1, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION, DURING VIRGIN IPP IMPLANTATION, THERE WAS A SUTURE NEEDLE PERFORATION ON THE RIGHT SIDE OF THE IMPLANT, WHICH THEN CAUSED THE SYSTEM TO REMOVE AND REPLACE THAT CYLINDER WITH A DIFFERENT LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944286 ↗
• InjuryMar 17, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621354 ↗
• InjuryMar 17, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING MALFUNCTION [FRACTURE].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620833 ↗
• InjuryMar 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO EROSION / EXTRUSION.

  Patient problems: Erosion

  MAUDE report 21572594 ↗
• InjuryFeb 7, 2025Material Frayed; Material Frayed

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO TUBING FRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333845 ↗
• InjuryFeb 4, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO BROKEN TUBING THAT LEFT THE RESERVOIR EMPTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304197 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 20784319 ↗
• InjuryNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20781067 ↗
• MalfunctionNov 4, 2024Pumping Problem; Pumping Problem

  ACCORDING TO THE AVAILABLE INFORMATION, AFTER PREPARATION OF AN IMPLANT WITHOUT ISSUE, AND SUCCESSFUL IMPLANTATION OF THE PUMP AND CYLINDERS, THE PUMP WOULD NOT REFILL. IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER DEVICE SUCCESSFULLY DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599885 ↗
• InjuryNov 4, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING BREAK THAT LED TO FLUID LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598226 ↗
• InjuryOct 30, 2024Deflation Problem; Inadequacy of Device Shape and/or Size; Deflation Problem; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE IMPLANT BEING UNDERSIZED & THE PATIENT COULD NOT USE IT CORRECTLY TO DEFLATE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20566734 ↗

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-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; 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-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis

…and 2 more.