Titan ESR822Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05708932487580), received between Jul 31, 2017 and Apr 13, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED DUE TO PATIENT NOT BEING ABLE TO GET ERECT ENOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858106 ↗
• InjuryAug 12, 2025Fracture; Pumping Problem; Fracture; Pumping Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WOULD NOT PUMP DUE TO A POSSIBLE BREAK IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787577 ↗
• InjuryMay 8, 2024Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO CRACKED TUBING AT THE JUNCTION WHERE THE TUBING TAPERS DOWN FROM THE RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19272209 ↗
• InjuryNov 27, 2023Fluid/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 18209464 ↗
• InjuryNov 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO FLUID LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187128 ↗
• InjuryMar 17, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565497 ↗
• InjuryJan 31, 2022Migration; Migration

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO PENDING EROSION AND CORPORAL PERFORATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 13401762 ↗
• MalfunctionSep 16, 2020Leak/Splash; Leak/Splash

  THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE ADDITIONAL EVENT INFORMATION RECEIVED FOR RECORD # (B)(4). ACCORDING TO THE AVAILABLE INFORMATION THE INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON (B)(6) 2013 AND REMOVED/REPLACED ON (B)(6) 2020 DUE TO LEAKAGE. ADDITIONAL INFORMATION RECEIVED FROM THE TERRITORY MANAGER INDICATED: ¿LEAK ¿ UNKNOWN ORIGIN¿ WAS REPORTED. THE DEVICE WAS NOT RECEIVED FOR EVALUATION AS IT WAS DISCARDED. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE QUALITY CANNOT CONFIRM ANY OBSERVATIONS OR COMMENT ON THE CONDITION OF THE PRODUCT. IF THE DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT WILL BE RE-EVALUATED ACCORDING TO PROCEDURES. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE REVEALED NO TRENDS FOR THIS LOT. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCES FOR THIS LOT. NO CAPAS ARE ASSOCIATED WITH THIS LOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10542735 ↗
• InjuryDec 4, 2019Migration; Migration

  ACCORDING TO THE AVAILABLE INFORMATION, BOTH CYLINDERS WERE FOUND ON THE RIGHT SIDE. ANOTHER INFLATABLE DEVICE WAS IMPLANTED.

  Patient problems: No Information

  MAUDE report 9413614 ↗
• InjuryJul 9, 2019Mechanical Problem; Mechanical Problem

  ACCORDING TO THE AVAILABLE INFORMATION, MALFUNCTION.

  Patient problems: No Information

  MAUDE report 8773191 ↗
• InjuryApr 10, 2018Extrusion

  ACCORDING TO THE AVAILABLE INFORMATION, EXTRUSION.

  Patient problems: No Information

  MAUDE report 7418207 ↗
• InjuryJan 10, 2018Hole In Material

  ACCORDING TO THE AVAILABLE INFORMATION, TITAN OTR WAS EXPLANTED DUE TO PINHOLE IN RESERVOIR TUBING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7179781 ↗
• InjuryJul 31, 2017Inflation Problem; Device Inoperable

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT STATED THAT HE HAS ALWAYS HAD ISSUES WITH THE IMPLANT INFLATING, HE ALSO STATED THAT HE WAS INFORMED THAT THE TUBING FROM THE RESERVOIR CAUSED HERNIA. HE RECENTLY HAD HERNIA SURGERY, NOW THE IMPLANT DOESN'T WORK AT ALL. THE HERNIA SURGERY WAS PERFORMED IN (B)(6) 2017.

  Patient problems: Failure of Implant; Hernia

  MAUDE report 6753437 ↗

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-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; 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-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis

…and 3 more.