Devices › Catheter, retention type, balloon
Device brand name · Silicone catheter
All Silicone Catheter: medical device reports filed with FDA
170 reports name it, 2018–2025. Manufacturer given most often on reports: C R Bard Covington -1018233. Product code EZL.
- 170
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 10
- reports, 12 months to August 2026
- 14 in the 12 months before
- 81.2%
- classified as malfunction
- 86.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
170 medical device reports received by FDA name the brand "All Silicone Catheter" (silicone catheter); the manufacturer given most often on reports is C R Bard Covington -1018233; received from February 2018 to September 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
10 reports arrived in the 12 months to August 2026, down 29% from 14 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 (81.2%) and injury (18.8%); 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 difficult to remove (11.2%), material puncture/hole (11.2%) and deflation problem (9.4%). The patient problems coded most often are urinary tract infection, pain and appropriate clinical signs, symptoms and conditions term/code not available. 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 |
|---|---|---|---|
| Difficult to removethe device was hard to remove | 19 | 11.2% | 6.3% |
| Material puncture/hole | 19 | 11.2% | 9.3% |
| Deflation problem | 16 | 9.4% | 11% |
| Fluid/blood leak | 14 | 8.2% | 8.8% |
| Material invagination | 13 | 7.6% | 2.7% |
| Leak/splashthe device leaked | 10 | 5.9% | 3.7% |
| Breakthe device broke | 8 | 4.7% | 4.4% |
| Material rupture | 7 | 4.1% | 6.3% |
| Mushroomed | 7 | 4.1% | 1.1% |
| Decrease in pressure | 6 | 3.5% | 2.5% |
| Inaccurate flow rate | 6 | 3.5% | 1.6% |
| Device dislodged or dislocated | 5 | 2.9% | 2% |
| Material protrusion/extrusion | 5 | 2.9% | 0.7% |
| Burst container or vessel | 4 | 2.4% | 10.8% |
| No flow | 4 | 2.4% | 0.8% |
| Partial blockage | 4 | 2.4% | 1.7% |
| Patient device interaction problem | 4 | 2.4% | 0.5% |
| Device fell | 3 | 1.8% | 0.8% |
| Difficult to insertthe device was hard to insert | 3 | 1.8% | 0.5% |
| Incorrect measurementthe device measured wrongly | 3 | 1.8% | 0.5% |
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 |
|---|---|---|
| Urinary tract infectionbladder or urinary infection | 15 | 8.8% |
| Painpain, site not specified | 13 | 7.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 11 | 6.5% |
| Discomfortdiscomfort | 10 | 5.9% |
| Hematuria | 4 | 2.4% |
| Tissue damage | 4 | 2.4% |
| Foreign body in patientpart of a device left in the patient | 3 | 1.8% |
| Burning sensationa burning feeling | 2 | 1.2% |
| Erosion | 2 | 1.2% |
| Injurya physical injury | 2 | 1.2% |
| Skin discoloration | 2 | 1.2% |
| Tissue breakdown | 2 | 1.2% |
| Urinary retentionbeing unable to empty the bladder | 2 | 1.2% |
| Deaththe patient died; cause not stated by this term | 1 | 0.6% |
| Hemorrhage/blood loss/bleeding | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | All Silicone Catheter | Product code EZL | All MAUDE reports |
|---|---|---|---|
| Reports | 170 | 9,394 | 26,136,888 |
| Share of that pool | — | 1.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 18.8% | 13% | 36.2% |
| Classified as malfunction | 81.2% | 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% |
| X-Flow prostatectomy catheter | 205 | 97 | 0% |
| Folysil Catheter | 188 | 0 | 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 All Silicone Catheter reports
How many FDA reports name All Silicone Catheter?
170 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 10 in the latest 12 months.
What kinds of events are reported?
malfunction (81.2%) and injury (18.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult to remove (11.2%), material puncture/hole (11.2%), deflation problem (9.4%), fluid/blood leak (8.2%) and material invagination (7.6%). 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 All Silicone 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.