Devices › Catheter, urological
Device brand name · Catheter retention type balloon
Foley Catheter: medical device reports filed with FDA
262 reports name it, 1992–2025. Manufacturer given most often on reports: Unomedical Sdn Bhd. Product code KOD.
- 262
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 2
- reports, 12 months to August 2026
- 13 in the 12 months before
- 63.7%
- classified as malfunction
- 80.8% across the product code
- 0.8%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 262 reports that name the brand "Foley Catheter" (catheter retention type balloon), received between July 1992 and December 2025; the manufacturer given most often on reports is Unomedical Sdn Bhd. Spellings of one product vary from report to report.
2 reports arrived in the 12 months to August 2026, down 85% from 13 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 (63.7%), injury (29.4%) and other (3.1%); across all catheter, urological reports (product code KOD) death is recorded in 0.2% and malfunction in 80.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are deflation problem (14.9%), break (4.6%) and device operates differently than expected (4.2%). The patient problems coded most often are discomfort, 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 17,205 reports carrying product code KOD. 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 |
|---|---|---|---|
| Deflation problem | 39 | 14.9% | 8.3% |
| Breakthe device broke | 12 | 4.6% | 3.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 11 | 4.2% | 2.4% |
| Difficult to removethe device was hard to remove | 11 | 4.2% | 6.8% |
| Material rupture | 10 | 3.8% | 4.1% |
| Fluid/blood leak | 8 | 3.1% | 2.4% |
| Burst container or vessel | 6 | 2.3% | 6.4% |
| Leak/splashthe device leaked | 6 | 2.3% | 1.6% |
| Infusion or flow problema problem with flow or infusion | 5 | 1.9% | 0.1% |
| Material integrity problema problem with the device material | 5 | 1.9% | 2.9% |
| Material puncture/hole | 5 | 1.9% | 2.5% |
| Split | 5 | 1.9% | 0.1% |
| Suction problem | 5 | 1.9% | 0% |
| Hole in material | 4 | 1.5% | 0.3% |
| Material split, cut or torn | 4 | 1.5% | 0.8% |
| Partial blockage | 4 | 1.5% | 1.3% |
| Device dislodged or dislocated | 3 | 1.1% | 0.4% |
| Device, or device fragments remain in patient | 3 | 1.1% | 0.2% |
| Material perforation | 3 | 1.1% | 0% |
| Decrease in suction | 2 | 0.8% | 0% |
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 | 12 | 4.6% |
| Painpain, site not specified | 10 | 3.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 6 | 2.3% |
| Urinary retentionbeing unable to empty the bladder | 5 | 1.9% |
| Bleeding | 4 | 1.5% |
| Confusion/ disorientation | 4 | 1.5% |
| Surgical procedure | 4 | 1.5% |
| Hemorrhage/blood loss/bleeding | 3 | 1.1% |
| Urinary tract infectionbladder or urinary infection | 3 | 1.1% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.8% |
| Low blood pressure/ hypotension | 2 | 0.8% |
| No patient involvement | 2 | 0.8% |
| Other (for use when an appropriate patient code cannot be identified) | 2 | 0.8% |
| Sepsisa severe body-wide response to infection | 2 | 0.8% |
| Urinary incontinenceleaking urine | 2 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Foley Catheter | Product code KOD | All MAUDE reports |
|---|---|---|---|
| Reports | 262 | 17,205 | 26,136,888 |
| Share of that pool | — | 1.5% | 0% |
| Classified as death, per 1,000 reports | 8 | 2 | 9 |
| Classified as injury | 29.4% | 16.7% | 36.2% |
| Classified as malfunction | 63.7% | 80.8% | 62.3% |
| Filed by the manufacturer | 45.4% | 89.2% | 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 KOD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Bardex Foley Catheter Silicone Coated | 1,876 | 306 | 0.1% |
| Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve | 1,505 | 71 | 0.1% |
| Magic3 Intermittent Catheter with Sure-Grip Sleeve | 1,400 | 22 | 0% |
| Bardia Foley Catheter Silicone Coated | 2,420 | 193 | 0% |
| Personal Catheter Intermittent Catheter | 684 | 12 | 0% |
| Magic3 Intermittent Catheter | 530 | 11 | 0% |
| Bardex Lubricath Foley Catheter | 4,923 | 653 | 0% |
| Gentlecath Glide | 1,067 | 73 | 0% |
| Bardia Coude Olive Tip Urethral Foley Catheter | 381 | 15 | 0% |
| Gentlecath Other | 307 | 0 | 0% |
| Gentlecath | 402 | 399 | 0% |
| Bardex Lubricath Hematuria Foley Catheter | 211 | 32 | 0% |
| Rochester Magic3 Coude Hydrophlic 14fr Male 30bx | 211 | 0 | 0% |
| Bard Tiemann Model Urological Catheter Coude Tip | 208 | 33 | 0% |
| Bard | 1,124 | 2 | 1.8% |
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 Foley Catheter reports
How many FDA reports name Foley Catheter?
262 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2 in the latest 12 months.
What kinds of events are reported?
malfunction (63.7%), injury (29.4%) and other (3.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
deflation problem (14.9%), break (4.6%), device operates differently than expected (4.2%), difficult to remove (4.2%) and material rupture (3.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (45.4%), voluntary reports (34.7%) and distributor reports (1.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Foley 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.