SureStep™ Foley Tray System Bardex® IC Complete Care® A303314ARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741073786), received between Apr 18, 2017 and Oct 20, 2021 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 25, 2026Class IIOpen, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3116-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2021Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH SOME BARD FOLEY KITS WHERE THE FOLEYS WERE NOT PROPERLY LABELED WITH THE LATEX WARNING STICKER. IT WAS STATED THAT VET HAD ORDER FOR A FOLEY PLACEMENT, ALLERGIES VERIFIED NO ALLERGY TO LATEX NOTED AND ORIGINAL ORDERED READ TO PLACE A 16F FOLEY AND IF NOT SUCCESSFUL TO PLACE A 14F FOLEY. IT WAS STATED THAT WHEN INSPECTING THE FOLEY KITS CATHER KITS REFERENCE NUMBERS A303316A FOR 16 FRENCH FOLEY CATH KIT AND A303314A 14 FRENCH FOLEY CATH KIT, ONE HAD A LABEL WITH A WARNING FOR LATEX AND THE OTHER DID NOT. IT WAS ALSO STATED THAT THE WARNING LABEL SHOULD BE DOCUMENTED ON ALL KITS AND THE ACTUAL PRODUCT WARNING WAS HARD TO SEE AS IT WAS ON THE SEEM OF THE PRODUCT (MATERIAL: A303316A AND A303314A). IT WAS ALSO STATED THAT IF THIS WAS A PATIENT WHO HAD AN ALLERGY THEY COULD BE HARMED AS THERE WERE NO KITS WITHOUT LATEX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666264 ↗
• MalfunctionNov 5, 2019Material Twisted/Bent; Output below Specifications; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WAS LOW OUTPUT OBSERVED OVER LONG PERIODS. THE NURSING PRACTICE COUNCIL RAISED AND LOWERED THE TUBING AND INCREASED GRAVITY TO DRAIN. THE TUBING BENT AT THE JUNCTION. IT WAS DIFFICULT TO DRAIN, BUT THERE WERE NO BLOCKAGES. THERE WERE 4 KITS USED. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 1NOV2019, THE TUBING THAT WAS MANIPULATED WAS BETWEEN THE BAG AND THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9282560 ↗
• MalfunctionOct 15, 2019Short Fill; Manufacturing, Packaging or Shipping Problem; Short Fill

  IT WAS REPORTED THAT A 14F FOLEY KIT WAS OPENED UP AND THE SALINE 10 ML SYRINGE ONLY HAD 2 ML IN IT. PER ADDITIONAL INFORMATION RECEIVED ON 04OCT2019, THE SYRINGE HAD A CAP IN PLACE AND THERE WAS NO INDICATION OF LIQUID IN THE TRAY OR ON ANY OTHER TRAY COMPONENTS. THE TRAY WAS NOT USED. A SECOND NEW TRAY WAS OBTAINED AND USED FOR THE PATIENT WITH NO ISSUES.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9194258 ↗
• MalfunctionSep 19, 2019Incorrect Measurement

  OPENED UP A 14F FOLEY KIT AND THE SALINE 10ML SYRINGE ONLY HAD 2ML IN IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9086447 ↗
• MalfunctionAug 21, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT THE STERILE WATER SYRINGE TO INFLATE THE BALLOON ONLY HAD 1-5MLS OF FLUID AND THE REST WAS AIR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8917688 ↗
• MalfunctionAug 9, 2019Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG HAD TO BE MANIPULATED IN ORDER FOR URINE TO FLOW. THE PATIENTS WERE RETAINING URINE IN THEIR BLADDERS.

  Patient problems: Urinary Retention

  MAUDE report 8880064 ↗
• MalfunctionJan 28, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT THE BARDEX IC FOLEY CATHETER LEAKED FROM THE VALVE BELOW THE BALLOON PORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8281943 ↗
• MalfunctionJan 25, 2018Leak/Splash

  CLINICAL MANAGER OBSERVED LEAKING INDWELLING FOLEY CATHETER. CATHETER WAS INSPECTED TO DETERMINE SOURCE OF LEAK. FOLEY CATHETER BAG WITH URIMETER. LEAK NOTED TO BE FROM URIMETER AT GREEN SPOUT. WHEN SPOUT WAS TURNED TO CLOSED POSITION, SPOUT WAS NOT FULLY CATCHING IN THREADS CAUSING FOLEY TO LEAK.

  Patient problems: No Information

  MAUDE report 7218382 ↗
• MalfunctionNov 17, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT WHEN THE FOLEY TRAY WAS OPENED, THE SYRINGE ONLY CONTAINED 5 ML OF STERILE WATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7042531 ↗
• MalfunctionOct 17, 2017Component Missing

  IT WAS REPORTED THAT THERE WERE NO CATHETERS IN THE TRAY. THE COMPLAINANT NOTED THAT ANOTHER TRAY WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6955545 ↗
• MalfunctionApr 18, 2017Component Missing

  IT WAS REPORTED THAT THE CAP OF THE WATER SYRINGE WAS MISSING; HOWEVER, NONE OF THE WATER LEAKED. THE STAFF MEMBER THAT NOTICED THE MISSING CAP, USED THE TRAY; HOWEVER, OBTAINED A DIFFERENT WATER SYRINGE AS A PRECAUTION. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6501016 ↗
• MalfunctionApr 18, 2017Component Missing

  IT WAS REPORTED THAT THE CAP OF THE LUBRICANT SYRINGE WAS MISSING; HOWEVER, NONE OF THE LUBRICANT LEAKED. THE STAFF MEMBER THAT NOTICED THE MISSING CAP, USED THE TRAY; HOWEVER, OBTAINED A DIFFERENT LUBRICANT SYRINGE AS A PRECAUTION. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6500655 ↗