Device: Coloplast Titan (inflatable penile prosthesis) | Period: July 2026 | Pulled: 2026-08-06
Total reports: 158 (Jul 1 – Jul 31, 2026)
Lifespan & Age at Mechanical Malfunction: Summary statistics
N: 65 / 158 (mechanical, dated)
Median: 6 yrs
Mean: 6 yrs
Max: 23 yrs
Median patient age: 68 (n = 54 of 65 with age reported)
Percent distribution
- ≤ 1 yr: 13.8%
- >1–4 yrs: 24.6%
- 5–10 yrs: 49.2% ← highest concentration
- 11–15 yrs: 6.2%
- 16–20 yrs: 4.6%
- 21–25 yrs: 1.5%
Note: Tubing fracture and tubing leakage together account for 55 of the 72 mechanical reports (roughly three quarters). Eighteen of this month's 158 reports had no narrative published at the time of the pull and are counted under Other / Unclear on that basis; see the second Note below.
Summary of Events: All 158 reports
- Infection: 22 of 158 reports (13.9%)
- Most are short administrative entries: the device was removed and, in the majority of cases, replaced with a malleable Genesis, with no organism culture or symptom detail given beyond the word "infection." Six were explanted and deliberately not replaced, leaving the patient without an implant.
- A few carry case-specific detail: one infection suspected on history and labs and then confirmed by later testing; one presenting in the scrotum, where the surgeon washed out the area and fitted a new clean pump rather than removing the whole device; one identified intraoperatively after the patient had come in for a size revision, with the surgery converted to a washout and malleable replacement; and one salvage procedure for infection together with urethral perforation following an earlier revision, where the report states plainly that the device itself had not malfunctioned.
- None of this month's infection reports attribute the infection to a device fault.
- Malfunction: 72 of 158 reports (45.6%), the largest category
- Tubing Fracture is the largest subcategory (32 reports): tubing described as broken, cracked, fractured or defective, most often at or just above the pump, and in the remainder at the cylinder junction, the reservoir tubing, or a strain-relief section. Several narratives arrive at the fracture only after a first report of the device no longer holding fluid, with the fracture confirmed at revision.
- Leakage without a stated fracture (a tubing leak, a general loss of fluid, an unidentified leak in the reservoir area, or a system found empty) accounts for 23 reports, most sharing near-identical short wording.
- Pump Failure accounts for 5 reports: a pump found broken at explant, a pump sticking, a pump that had gone rock hard and could not be squeezed, a valve stuck so that fluid would not circulate, and a pump that collapsed and stuck each time the device was inflated.
- Material Puncture (4 reports) covers a hole found in the reservoir, a cylinder puncture, a pump perforation, and a perforation in the system that had emptied the reservoir. Auto-inflation and Material Frayed account for 3 reports each, the latter all describing frayed tubing at or near the pump.
- One intraoperative failure was caught before implantation: during preparation and purging, the hydraulic system could not be fully filled and the pump showed abnormal rigidity, so the device was swapped for a second prosthesis that prepared and implanted normally. One further report describes air in the system, grouped as unspecified/other mechanical.
- Full breakdown by cause (72 total): Tubing Fracture (32); Leakage (23); Pump Failure (5); Material Puncture (4); Auto-inflation (3); Material Frayed (3); Intraoperative (1); unspecified/other mechanical (1).
- Malposition: 13 of 158 reports (8.2%)
- Erosion, confirmed rather than impending, is the largest subgroup (4 reports), each describing an explant and replacement with no device fault stated. A fifth report describes impending erosion of a cylinder, caught and revised before it broke through.
- Migration (2 reports) covers a reservoir that migrated and a pump that migrated and developed a tubing bulge five months after a revision. Reservoir Herniation accounts for a further 2 reports, both herniated reservoirs removed and replaced.
- General positioning issues account for 2 reports: a reservoir that had to be moved to a sub-muscular location, and one placed subcuticularly in the wrong plane at the original implant.
- One report describes a crossover, managed by explanting a single cylinder and fitting a lock plug, and one an extrusion, where the incision opened and exposed the pump.
- Full breakdown by cause (13 total): Erosion, confirmed (4); general positioning (2); Migration (2); Reservoir Herniation (2); Crossover (1); Extrusion (1); Impending erosion (1).
- Patient Dissatisfaction: 8 of 158 reports (5.1%)
- Size accounts for 4 reports, three of them devices judged too long, one revised without rear tip extenders and one where the patient found the implant oversized and uncomfortable when inflated.
- Cosmetic concerns account for 3 reports, two of them unusually detailed accounts of appearance in the flaccid state: visible irregularities, protrusions and asymmetry in one, palpable "dog ears" in the other, both patients stating that rigidity had been restored but that the resting appearance affected body image and confidence. The third describes a pump placed where the patient found it too visible.
- One report describes pump operating effort: the patient reported that activating the device took significant force and often both hands, making use deliberate rather than discreet.
- Full breakdown by cause (8 total): Size (4); Cosmetic (3); pump operating effort (1).
- Other / Unclear: 43 of 158 reports (27.2%)
- Eighteen reports had no narrative text published at the time of this pull. The record exists and carries a product-problem code, but FDA had not yet posted the event description, so no cause can be read from them. They are counted here rather than assigned to a cause on the strength of a code alone.
- Eight further reports give no usable cause: each restates a MedWatch entry describing surgery on a previous non-Coloplast device for unspecified or unknown reasons, with a new prosthesis implanted and nothing further recorded.
- Five reports describe a surgical or iatrogenic cause: a cylinder punctured by a suture needle, a proximal tissue perforation that folded a cylinder inward, a hematoma, scrotal pain with a possible hematoma, and a revision performed for a corporoplasty.
- Four report a clinical complication with no device fault: inability to ejaculate or orgasm after implantation alongside low testosterone, scrotal fluid leaking from the incision, pain in the scrotum, and acute kidney failure traced to inflammation near the prostate blocking urine flow.
- Two describe an assembly-kit issue: collars that slid over their connectors without locking, and a rubber shod from the kit that went missing during a procedure and could not be accounted for. Two more state only an "unspecified malfunction" against an insufficient-information code, and two record no device fault at all (a patient having trouble deflating a pump reported to be working normally, and a pump that was sticky during testing but filled normally before implantation). One describes a package labelled as a narrow device that contained a standard one, and one a device implanted from a lot that had already expired, with no fault reported.
- Full breakdown by cause (43 total): narrative not published (18); no reason documented (8); surgical or iatrogenic (5); clinical complication (4); assembly-kit issue (2); no device fault identified (2); unspecified malfunction against an insufficient-information code (2); expired lot (1); labelling or packaging error (1).
Note: This month was pulled six days after the period closed, and FDA had not yet published the event description for 18 of the 158 reports (11.4%). The gap is concentrated in the final week: none of the reports received through July 21 are affected. Those 18 are counted under Other / Unclear because a cause cannot be read from a product-problem code alone, so the Malfunction, Infection, Malposition and Dissatisfaction counts above should each be read as a floor rather than a settled figure.
Data Source
FDA's public MAUDE database
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. The incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information. Submission of a medical device report and the FDA's release of that information is not necessarily an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event.
