Titan ES2820Recalls & reported problems

Summary

The FDA's MAUDE database contains 232 adverse event reports that list this exact device (DI 05708932539135), received between Jul 24, 2017 and Jun 9, 2026 — classified as 204 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (29 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 232 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Inadequacy of Device Shape and/or Size

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448513 ↗
• InjuryMay 20, 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 25229610 ↗
• InjuryMay 4, 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 25072483 ↗
• InjuryApr 9, 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 EROSION.

  Patient problems: Erosion

  MAUDE report 24830095 ↗
• InjuryMar 30, 2026Fluid/Blood Leak; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715960 ↗
• InjuryMar 23, 2026Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED AS THE DOCTOR SUSPECTED A LEAK; HOWEVER, THE LEAK WAS NOT IDENTIFIED DURING THE EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662340 ↗
• InjuryMar 16, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED DUE TO BROKEN TUBING FROM THE RESERVOIR TO THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611981 ↗
• InjuryFeb 24, 2026Insufficient Device Problem Information

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

  Patient problems: Pain

  MAUDE report 24430574 ↗
• InjuryFeb 20, 2026Malposition of Device; Pumping Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PUMP DIFFICULT TO PUMP & RESERVOIR PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24404531 ↗
• InjuryFeb 18, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO INCORRECT SIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377655 ↗
• InjuryFeb 18, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377451 ↗
• 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 A SCROTAL INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24200493 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP BULB HAS ATTACHED TO PATIENT'S INNER SCROTUM. THE PATIENT HAD A STAPH INFECTION POST IMPLANTATION PROCEDURE THAT LASTED MULTIPLE MONTHS. THE FIRST DOCTOR REPORTEDLY SAW NO ISSUES; HOWEVER, A SECOND DOCTOR NOTED POSSIBILITY FOR EROSION ISSUES AND RECOMMENDED REPLACEMENT OF PUMP.

  Patient problems: Adhesion(s); Bacterial Infection

  MAUDE report 24163949 ↗
• MalfunctionJan 14, 2026Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT IS UNABLE TO DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073029 ↗
• MalfunctionJan 13, 2026Unintended Deflation

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WILL NOT STAY RIGID [AUTO-DEFLATION].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059610 ↗
• InjuryJan 5, 2026Fluid/Blood Leak; Pumping Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE A LEAK IN THE RESERVOIR TUBING. THE DEVICE WOULDN'T PUMP AFTER 5 CYCLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956147 ↗
• InjuryJan 2, 2026Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950655 ↗
• InjuryDec 18, 2025Failure to Pump; Failure to Pump

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PUMP NON-FUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838302 ↗
• InjuryDec 11, 2025Material Deformation; Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN ANEURYSM OF THE CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778921 ↗
• InjuryNov 20, 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 INCORRECT SIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604909 ↗
• InjuryNov 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO WHAT APPEARED TO BE A LEAK WITH THE CONNECTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450409 ↗
• InjuryOct 30, 2025Malposition of Device; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO POSSIBLE EXTRUSION [EROSION]. THE IMPLANT ON THE LEFT SIDE FOLDED ON TO ITSELF AND WOULD NOT STRAIGHTEN OUT.

  Patient problems: Erosion

  MAUDE report 23430454 ↗
• InjuryOct 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 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23254551 ↗
• InjuryAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22706162 ↗
• InjuryJul 8, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A HOLE IN THE CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440090 ↗

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-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
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; 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-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; 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-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
• 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-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis

…and 3 more.