Devices › Catheter, retention type, balloon
Device brand name · Indwelling urethral drainage balloon catheter non-antimicrobial
X-Flow prostatectomy catheter: medical device reports filed with FDA
205 reports name it, 2023–2026. Manufacturer given most often on reports: Coloplast A/S. Product code EZL.
- 205
- device reports naming the brand
- 0% of all MAUDE reports · about 68 a year
- 97
- reports, 12 months to August 2026
- 35 in the 12 months before
- 91.7%
- classified as malfunction
- 86.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
205 medical device reports received by FDA name the brand "X-Flow prostatectomy catheter" (indwelling urethral drainage balloon catheter non-antimicrobial); the manufacturer given most often on reports is Coloplast A/S; received from July 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
97 reports arrived in the 12 months to August 2026, up 177% from 35 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (91.7%) and injury (8.3%); across all catheter, retention type, balloon reports (product code EZL) death is recorded in 0.1% and malfunction in 86.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are burst container or vessel (49.3%), unintended deflation (15.6%) and device contaminated during manufacture or shipping (10.2%). The patient problems coded most often are discomfort, pain and hematuria. FDA states that "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. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 9,394 reports carrying product code EZL. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Burst container or vessel | 101 | 49.3% | 10.8% |
| Unintended deflation | 32 | 15.6% | 1.1% |
| Device contaminated during manufacture or shipping | 21 | 10.2% | 0.6% |
| Improper or incorrect procedure or method | 20 | 9.8% | 0.6% |
| Material rupture | 15 | 7.3% | 6.3% |
| Failure to deflate | 11 | 5.4% | 1.3% |
| Fluid/blood leak | 10 | 4.9% | 8.8% |
| Fracturea broken bone | 9 | 4.4% | 0.8% |
| Off-label use | 7 | 3.4% | 0.2% |
| Delivered as unsterile product | 4 | 2% | 0.2% |
| Device contamination with chemical or other material | 3 | 1.5% | 1.2% |
| Contamination | 2 | 1% | 0.1% |
| Device slipped | 2 | 1% | 0.7% |
| Material split, cut or torn | 2 | 1% | 2.8% |
| Tear, rip or hole in device packaging | 2 | 1% | 0.4% |
| Component misassembled | 1 | 0.5% | 0.8% |
| Contamination of device ingredient or reagent | 1 | 0.5% | 0% |
| Device handling problem | 1 | 0.5% | 0.1% |
| Inflation problem | 1 | 0.5% | 4.3% |
| Infusion or flow problema problem with flow or infusion | 1 | 0.5% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Discomfortdiscomfort | 28 | 13.7% |
| Painpain, site not specified | 24 | 11.7% |
| Hematuria | 7 | 3.4% |
| Foreign body in patientpart of a device left in the patient | 4 | 2% |
| Hemorrhage/blood loss/bleeding | 3 | 1.5% |
| Urinary retentionbeing unable to empty the bladder | 3 | 1.5% |
| Genital bleeding | 2 | 1% |
| Intraoperative pain | 2 | 1% |
| Septic shockshock arising from infection | 2 | 1% |
| Tissue irritation | 2 | 1% |
| Distress | 1 | 0.5% |
| Internal organ perforation | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | X-Flow prostatectomy catheter | Product code EZL | All MAUDE reports |
|---|---|---|---|
| Reports | 205 | 9,394 | 26,136,888 |
| Share of that pool | — | 2.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 8.3% | 13% | 36.2% |
| Classified as malfunction | 91.7% | 86.3% | 62.3% |
| Filed by the manufacturer | 100% | 91.9% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "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. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code EZL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Bardex Lubri-Sil All-Silicone Foley Catheter | 1,412 | 294 | 0.1% |
| Bardex All-Silicone Foley Catheter | 1,516 | 196 | 0% |
| Bardex Lubri-Sil I.C. All-Silicone Foley Catheter | 3,131 | 620 | 0% |
| Folysil silicone catheter | 335 | 89 | 0.6% |
| Bard Silastic Foley Catheter | 246 | 90 | 0% |
| Bardex Lubri-Sil All-Silicone Temp Sensing Foley Catheter | 248 | 62 | 0% |
| Brillant 2-W Silicone Foley Cylindrical | 248 | 0 | 0% |
| Folysil Catheter | 188 | 0 | 0% |
| All Silicone Catheter | 170 | 10 | 0% |
| Bardia All-Silicone Foley Catheter | 176 | 8 | 0% |
| Foley Catheter | 262 | 2 | 0.8% |
| Medline | 26,935 | 26,184 | 0.1% |
| Bard | 1,124 | 2 | 1.8% |
| Surestep | 5,323 | 0 | 0.1% |
| Dover | 171 | 32 | 0.6% |
Ordered by report count for navigation only. FDA states that "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. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about X-Flow prostatectomy catheter reports
How many FDA reports name X-Flow prostatectomy catheter?
205 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 97 in the latest 12 months.
What kinds of events are reported?
malfunction (91.7%) and injury (8.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
burst container or vessel (49.3%), unintended deflation (15.6%), device contaminated during manufacture or shipping (10.2%), improper or incorrect procedure or method (9.8%) and material rupture (7.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that X-Flow prostatectomy catheter was at fault?
No. FDA states that "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. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.