Titan 90-9816INCRecalls & reported problems

Coloplast A/S · Infrapubic Bioflex® Cylinder Set with Pump - Narrow · Class 3 · Implant

All models of Titan (62)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 5
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05708932322348), received between Sep 13, 2018 and Mar 19, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem2
Break1
Fracture1
Insufficient Device Problem Information1
Physical Resistance/Sticking1
Positioning Problem1

Patient problems

Unspecified Infection2
Abscess1
Erosion1
No Clinical Signs, Symptoms or Conditions1
No Consequences Or Impact To Patient1
No Information1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

InjuryMar 19, 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 IMPENDING EROSION.
Patient problems: Erosion
MAUDE report 21642952 ↗
InjuryDec 27, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A STICKY PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026549 ↗
InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO INFECTION. THE PATIENT HAD FLUID COLLECTION/ABSCESS. A MALLEABLE DEVICE WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Abscess; Unspecified Infection
MAUDE report 15620744 ↗
MalfunctionAug 7, 2020Positioning Problem; Positioning Problem
ACCORDING TO THE AVAILABLE INFORMATION, EXCHANGED CYLINDERS ONLY TO REPOSITION AND FIXATE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10381948 ↗
InjuryFeb 3, 2020Break; Fracture; Break; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS SEPARATION NOTED IN THE PUMP BULB. THE DEVICE WAS REPLACED WITH ANOTHER INFLATABLE PROSTHESIS.
Patient problems: No Information
MAUDE report 9662234 ↗
InjurySep 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7873708 ↗

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-1359-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
Z-1375-2023 · Mar 1, 2023 · Open, Classified
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
Z-1371-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
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-1361-2023 · Mar 1, 2023 · Open, Classified
Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
Z-1369-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; 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-1360-2023 · Mar 1, 2023 · Open, Classified
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
Z-1365-2023 · Mar 1, 2023 · Open, Classified
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
Z-1362-2023 · Mar 1, 2023 · Open, Classified
Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
Z-1363-2023 · Mar 1, 2023 · Open, Classified
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
Z-1370-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
Z-1373-2023 · Mar 1, 2023 · Open, Classified
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis

…and 3 more.

Device details

UDI-DI	`05708932322348`
Brand	Titan
Model	90-9816INC
Company	Coloplast A/S
Product code	FHW · Device, Impotence, Mechanical/Hydraulic
Class	Class 3
FDA submission	P000006
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Inflatable penile prosthesis

An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is available in a variety of designs and materials and typically consists of: 1) one or two inflatable cylinders implanted into the corpora cavernosa of the penis; 2) a subcutaneous manual pump bulb implanted into the scrotum; 3) a reservoir containing fluid (e.g., saline with/without radiopacifier) implanted in the abdomen; and 4) kink-resistant tubing that connect the component parts.

Other Device, Impotence, Mechanical/Hydraulic devices

Titan ES2920
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1 recall862 reports
Titan ES2922
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1 recall1 death758 reports
Titan ES2918
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577 reports
Titan ES8920
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1 recall476 reports
Titan ES8922
Coloplast A/S · Device, Impotence, Mechanical/Hydraulic
1 recall334 reports
Titan 517750
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1 recall258 reports
Titan ES8918
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1 recall225 reports
Titan ES2818
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1 recall222 reports

All Device, Impotence, Mechanical/Hydraulic devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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