Titan 90-9918SNCRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05708932323901), received between Jul 24, 2017 and Mar 3, 2026 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO CRACKED TUBING. IT WAS NOTED THAT THE DEVICE WAS 8 YEARS OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497457 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE LEFT CYLINDER WAS REMOVED AS THE IMPLANT HAD IMPENDING EROSION ON THE LEFT CYLINDER.

  Patient problems: Erosion

  MAUDE report 21137427 ↗
• InjuryNov 25, 2024Fluid/Blood Leak; Inflation Problem; Insufficient Device Problem Information; Fluid/Blood Leak; Inflation Problem; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772039 ↗
• InjuryOct 18, 2024Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A PUMP TUBING BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20487498 ↗
• InjuryJul 8, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690225 ↗
• InjuryMay 22, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981481 ↗
• InjuryJan 27, 2023Fracture; Fracture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING TEAR. A 1 CM TEAR ALONG THE TUBING WAS NOTED AT THE RIGHT CYLINDER AT THE POINT WHERE THE EXIT TUBING WAS COMING FROM THE TUNICA. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16255379 ↗
• InjuryOct 7, 2022Fracture; 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 15565269 ↗
• InjuryDec 28, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13101376 ↗
• InjuryNov 30, 2021Fracture; Fracture

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, TUBING BREAK NEAR THE PUMP. THE PUMP AND TUBING WERE REPLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12900622 ↗
• InjuryAug 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, A TUBING LEAK WAS NOTED ON THE CYLINDER TO PUMP TUBING. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337439 ↗
• InjuryJul 2, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED FOR A REAR TIP EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12109070 ↗
• MalfunctionOct 18, 2020Disconnection; Disconnection

  THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE ADDITIONAL EVENT INFORMATION RECEIVED FOR RECORD #615730. ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE DEVICE WAS IMPLANTED IN 2013 AND REMOVED/REPLACED ON (B)(6) 2020. INFORMATION RECEIVED FROM THE CLINICAL SALES REPRESENTATIVE INDICATED: ¿COLLARS ON RESERVOIR TUBING WAS DISCONNECTED. MINIMAL SALINE IN THE SYSTEM.¿ A TITAN PUMP, TWO CYLINDERS, AND RESERVOIR WERE RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED A SEPARATION IN THE BLADDER OF CYLINDER 1. TESTING REVEALED THIS TO BE A SITE OF LEAKAGE. MICROSCOPIC EXAMINATION OF THE SURFACES REVEALED THEM TO HAVE BURN LIKE MARKS, INDICATING CONTACT WAS MADE WITH CAUTERIZING INSTRUMENTATION. PARTIAL SEPARATIONS WITHIN ABRASION WERE NOTED ON BOTH PUMP EXHAUST TUBES, THE EXHAUST TUBING OF CYLINDER 1, AND THE RESERVOIR INLET TUBING. TESTING REVEALED THESE TO NOT BE SITES OF LEAKAGE. SURFACE ABRASION WAS NOTED ON THE PUMP INLET TUBING. BURN LIKE MARKS WERE NOTED ON THE BLADDER OF CYLINDER 2. TESTING REVEALED THIS TO NOT BE A SITE OF LEAKAGE. NO FUNCTIONAL ABNORMALITIES WERE NOTED WITH THE PUMP, CYLINDER 2, OR RESERVOIR. BECAUSE THESE COMPONENTS WERE

  Patient problems: Insufficient Information

  MAUDE report 10695075 ↗
• MalfunctionJun 10, 2020Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS LEAKAGE DUE TO A TUBING BREAK NEAR THE RESERVOIR. THE RESERVOIR WAS REMOVED/REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10139253 ↗
• InjuryApr 18, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION, MALFUNCTION - CYLINDERS PERFORATED.

  Patient problems: No Information

  MAUDE report 8529724 ↗
• InjuryDec 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8130968 ↗
• InjuryMar 20, 2018Device Inoperable

  ACCORDING TO THE AVAILABLE INFORMATION, PATIENT WITH A HISTORY OF ERECTILE DYSFUNCTION AND PEYRONIE'S DISEASE UNDERWENT PENILE IMPLANT IN 2017. THE PENILE IMPLANT IS NOT FUNCTIONING AND THE DEVICE WAS EXPLANTED.

  Patient problems: No Code Available; No Information

  MAUDE report 7352919 ↗
• InjuryJul 24, 2017Extrusion

  ACCORDING TO THE AVAILABLE INFORMATION: EROSION/EXTRUSION, NON-MALFUNCTION ISSUE. PATIENT PREFERENCE.

  Patient problems: Erosion

  MAUDE report 6737400 ↗

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-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; 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-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; 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-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; 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-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis

…and 3 more.