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FDA product code EZL · class 2 · Gastroenterology, Urology
Catheter, retention type, balloon: medical device reports filed with FDA
9,394 reports carry this product code, 1992–2026; 30 brands with a page.
- 9,394
- reports with this product code
- 0% of all MAUDE reports
- 1,174
- reports, 12 months to August 2026
- 1,306 in the 12 months before
- 86.3%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
Product code EZL is FDA's classification for "Catheter, retention type, balloon" (gastroenterology, Urology panel), a class 2 device. 9,394 medical device reports carry this product code, 0% of the MAUDE database, from June 1992 to August 2026.
1,174 reports arrived in the 12 months to August 2026, down 10% from 1,306 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 (86.3%), injury (13%) and other (0.3%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| C R Bard Covington -1018233 | 5,089 | 54.2% |
| Coloplast A/S | 1,182 | 12.6% |
| Teleflex Medical | 524 | 5.6% |
| Teleflex Medical Sdn Bhd | 513 | 5.5% |
| C R Bard | 489 | 5.2% |
| Productos Para El Cuidado De La Salud -9611590 | 347 | 3.7% |
| Unomedical Sdn Bhd | 256 | 2.7% |
| Medline Industries | 245 | 2.6% |
| Bard | 32 | 0.3% |
| Deroyal Industries | 3 | 0% |
| Convatec | 2 | 0% |
| Bard Access Systems | 1 | 0% |
| Bd | 1 | 0% |
| Datascope | 1 | 0% |
| Dow Corning | 1 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Deflation problem | 1,033 | 11% |
| Burst container or vessel | 1,019 | 10.8% |
| Material puncture/hole | 877 | 9.3% |
| Fluid/blood leak | 826 | 8.8% |
| Material rupture | 595 | 6.3% |
| Difficult to removethe device was hard to remove | 591 | 6.3% |
| Breakthe device broke | 414 | 4.4% |
| Inflation problem | 400 | 4.3% |
| Leak/splashthe device leaked | 351 | 3.7% |
| Material split, cut or torn | 262 | 2.8% |
| Material invagination | 251 | 2.7% |
| Decrease in pressure | 237 | 2.5% |
| Device dislodged or dislocated | 186 | 2% |
| Material fragmentation | 170 | 1.8% |
| Partial blockage | 163 | 1.7% |
| Inaccurate flow rate | 146 | 1.6% |
| Component missing | 141 | 1.5% |
| Material deformation | 132 | 1.4% |
| Failure to deflate | 126 | 1.3% |
| Erratic or intermittent display | 124 | 1.3% |
Questions about catheter, retention type, balloon reports
What is product code EZL?
FDA's classification code for "Catheter, retention type, balloon", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
9,394 reports through August 2026, 1,174 of them in the latest 12 months.
Which brands appear most often?
Bardex Lubri-Sil All-Silicone Foley Catheter (1,405), Bardex All-Silicone Foley Catheter (1,075), Bardex Lubri-Sil I.C. All-Silicone Foley Catheter (765), Folysil silicone catheter (335) and Bard Silastic Foley Catheter (246). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.