Titan ES8914Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05708932487306), received between Apr 19, 2019 and Mar 10, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559716 ↗
• InjuryJul 24, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO SIZE. A LARGER SIZE WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375821 ↗
• InjuryMay 17, 2023Fracture; Fracture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A FRACTURE. THERE WAS A HOLE IN THE TUBING BY THE PUMP. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948905 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, PATIENT HAD AN INFECTION IN THEIR SCROTUM. DEVICE WAS REPLACED WITH A GENESIS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 12888783 ↗
• InjuryDec 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION A TUBING DEFECT WAS REPORTED. THE DEVICE WAS EXCHANGED FOR ANOTHER INFLATABLE DEVICE.

  Patient problems: No Information

  MAUDE report 9535885 ↗
• InjuryDec 19, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE, WHICH HAD BEEN IMPLANTED TEN YEARS AGO, WAS UNABLE TO BE CYCLED TO INFLATE IT. IT WAS REPORTED THAT THE EVENT WAS OBSERVED TWO MONTHS AGO. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER DEVICE.

  Patient problems: No Information

  MAUDE report 9497723 ↗
• InjuryNov 27, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP TUBING WAS TOO SHORT. NO PRODUCT ISSUE WAS REPORTED. THE PUMP WAS REPLACED. IT WAS PLACED IN A FEW MONTHS PRIOR.

  Patient problems: No Information

  MAUDE report 9386473 ↗
• InjuryNov 18, 2019Break; Break

  ACCORDING TO THE AVAILABLE INFORMATION, A TUBING BREAK AT THE PUMP WAS REPORTED. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER INFLATABLE DEVICE.

  Patient problems: No Information

  MAUDE report 9336443 ↗
• InjurySep 13, 2019Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  ACCORDING TO THE AVAILABLE INFORMATION, ONLY THE REAR TIP EXTENDERS WERE REPLACED WITH A DIFFERENT SIZE. THE DEVICE APPEARED TO INFLATE/DEFLATE WITHOUT DIFFICULTY; HOWEVER THE RIGHT SIDE CYLINDER HAD CROSSOVER (DISTAL).

  Patient problems: No Information

  MAUDE report 9045414 ↗
• InjuryJul 3, 2019Mechanical Problem; Mechanical Problem

  ACCORDING TO THE AVAILABLE INFORMATION, MALFUNCTION.

  Patient problems: No Information

  MAUDE report 8761197 ↗
• InjuryJul 2, 2019Migration; Migration

  ACCORDING TO THE AVAILABLE INFORMATION, CROSSOVER OCCURRED DURING IMPLANT. THE INFLATABLE PENILE PROSTHESIS (IPP) WAS REPLACED WITH A NEW IPP.

  Patient problems: Tissue Damage

  MAUDE report 8755359 ↗
• InjuryJun 14, 2019Positioning Problem; Positioning Problem

  ACCORDING TO THE AVAILABLE INFORMATION, REPOSITIONING OF CYLINDERS.

  Patient problems: No Information

  MAUDE report 8699428 ↗
• InjuryJun 12, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE AVAILABLE INFORMATION, PROSTHESIS EXPLANTED DUE TO INFECTION, EROSION/EXTRUSION.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 8694170 ↗
• InjuryMay 10, 2019Break; Break

  ACCORDING TO THE AVAILABLE INFORMATION, TUBING BREAK NEXT TO THE CONNECTION TO THE CYLINDER, CLOSER TO THE PUMP.

  Patient problems: No Information

  MAUDE report 8601400 ↗
• InjuryMay 8, 2019Fracture; Fracture

  ADDITIONAL INFORMATION INDICATED THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED APPROXIMATELY 10 ½ YEARS AGO AND THE PUMP TUBING WAS FOUND CUT OFF ABOUT 2-3CM FROM THE PUMP.

  Patient problems: No Information

  MAUDE report 8593122 ↗
• InjuryMay 8, 2019Leak/Splash; Leak/Splash

  ADDITOINAL INFORMATION INDICATED THE DEVICE WAS IMPLANTED IN 2006.

  Patient problems: No Information

  MAUDE report 8593103 ↗
• InjuryApr 19, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  PER ADDITIONAL INFORMATION RECEIVED, EXTRUDED (R) CYLINDER.

  Patient problems: Erosion

  MAUDE report 8533877 ↗

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-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• 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-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-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; 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
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; 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-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis

…and 3 more.