Catheter, Coude
FDA adverse event reports and recall history for catheter, coude (product code EZC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 10,295
- Deaths
- 1
- Injuries
- 1,089
- Malfunctions
- 9,202
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 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.
- TerminatedProcess control
Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
Foley Catheter with Incorrect Retainer Cap Print
Monitor catheter, coude automatically
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