Catheter, Coude
FDA adverse event reports and recall history for catheter, coude (product code EZC), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 10,519
- Deaths
- 2
- Injuries
- 1,114
- Malfunctions
- 9,397
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-09-04Open, ClassifiedUnder Investigation by firm
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801 10801741024808 00801741024818 10801741024815 00801741024825 10801741024822 SureStep" Foley Tray System with Bardex Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707 SureStep" Foley Tray System Bard Lubricath Foley REF: A800361 UDI code: 00801741073939 10801741073936 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A899616 UDI code: 00801741104534 10801741104531 SureStep" Foley Tray System Bardex Lubricath Foley Catheter REF: A899914 UDI code: 00801741074004 10801741074001 SureStep" Foley Tray System Bardex Lubricath Foley Catheter REF: A899916 UDI code: 00801741074011 10801741074018 SureStep" Foley Tray System Bardex Lubricath Temperature Sensing Catheter REF: A900216 UDI code: 00801741120978 10801741120975 SureStep" Foley Tray System BardLubricath Foley Catheter REF: A902914 A902916 A902918 UDI code: 0080174107406610801741074063 00801741074073 10801741074070 0080174107408010801741074087 Bard Urine Meter Foley Catheter Tray With Bardex Lubricath Foley Catheter REF: 304916 UDI code: 00801741019736 01801741019739 Bard Urine Meter Foley Catheter Tray With Bardex Lubricath Foley Catheter REF: 902916 UDI codes: 00801741024863 10801741024860 (416A) SureStep Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep Foley Tray System Bardex IC Complete REF: A304914 A304916 A304918 UDI codes: 00801741104350 10801741104357 00801741104367 10801741104364 00801741100499 10801741100496 SureStep" Foley Tray System Bard Lubricath Foley REF: A800365 UDI codes: 00801741073960 10801741073967 SureStep" Foley Tray System Bardex Lubricath Foley Catheter REF: A899918 UDI codes: 00801741074028 10801741074025 SureStep" Foley Tray System BardLubricath Foley Catheter REF: A902618 UDI codes: 00801741104640 10801741104647 SureStep" Foley Tray System BardLubricath Foley Catheter REF: A902616 UDI codes: 00801741104633 10801741104630 SureStep Intermittent Catheter Tray REF: INTL16C UDI codes: 00801741183195 10801741183192 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- 2025-07-03Open, ClassifiedUnder Investigation by firm
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
Cather packaging may contain the incorrect French size.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-23Open, ClassifiedPackaging change control
Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2012-09-07TerminatedProcess control
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
Incomplete seal on sterile packages of product.
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