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Catheter, Urological
FDA product code KOD · Class 2 · Gastroenterology, Urology
1,843
Registered devices
17,279
Adverse events
108
Recalls
238
510(k) clearances
Devices with this code
Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve — C. R. Bard, Inc.Bardia® Coude Olive Tip Urethral Foley Catheter — C. R. Bard, Inc.GENTLECATH — CONVATEC, PURCHASING DEPARTMENTDover — Cardinal Health 200, LLCRUSCH — TELEFLEX INCORPORATEDRUSCH — TELEFLEX INCORPORATEDVan Andel — COOK INCORPORATEDUreteral Catheter — Well Lead Medical Co.,LtdDover — Cardinal Health, Inc.RUSCH — TELEFLEX INCORPORATEDFlexi-Tip — COOK INCORPORATEDBard® Robinson Catheter — C. R. Bard, Inc.MTG — HR PHARMACEUTICALS INC.MTG — HR PHARMACEUTICALS INC.Cook — COOK INCORPORATEDDover — Cardinal Health 200, LLCBard® Tiemann Model Urological Catheter Coude Tip — C. R. Bard, Inc.Dover — Cardinal Health 200, LLCRobinson — COOK INCORPORATEDNavigator — BOSTON SCIENTIFIC CORPORATIONRUSCH — TELEFLEX INCORPORATEDUnited Urologics Closed System Catheter — UNITED UROLOGICS INCRUSCH — TELEFLEX INCORPORATEDRUSCH — TELEFLEX INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-25 | C.R. Bard Inc | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
| 2025-06-03 | C.R. Bard Inc | Cather packaging may contain the incorrect French size. |
| 2025-06-03 | C.R. Bard Inc | Cather packaging may contain the incorrect French size. |
| 2023-12-04 | Cardinal Health 200, LLC | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2022-09-20 | TELEFLEX LLC | Product may not be sterile |
| 2022-01-27 | C.R. Bard Inc | There is a potential to leak from the catheter where it connects to the drain bag |
| 2022-01-27 | C.R. Bard Inc | There is a potential to leak from the catheter where it connects to the drain bag |
| 2021-01-11 | C.R. Bard, Inc. | The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. |
| 2020-04-30 | Covidien Llc | Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body tem |
| 2020-04-30 | Covidien Llc | Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body tem |
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