SureStep™ Foley Tray System Bardex® IC Complete Care® A303318ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741073809), received between Nov 20, 2017 and Oct 20, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

2 FDA recall records name this device's identifier, 2 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 ↗

2. Aug 5, 2021Class IIOpen, Classified

   There is potential for packaging defects that may impact the sterile barrier.

   Z-2526-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT THE URINARY CATHETER KIT CUSTOMER OBTAINED FROM ONE OF THE FLOORS WAS FOUND TO HAVE AN EMPTY STERILE WATER SYRINGE THAT WAS UTILIZED TO INFLATE THE URINARY BALLOON WAS EMPTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975424 ↗
• MalfunctionJul 12, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT STAFF USED THE FOLEY TRAY AND DURING PROCEDURE IT WAS IDENTIFIED THAT THE LUBE WAS MISSING FROM THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988969 ↗
• 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 9282661 ↗
• MalfunctionNov 20, 2017Kinked

  IT WAS REPORTED THAT THE TUBING OF THE DRAIN BAG WAS KINKED. THE COMPLAINANT ALLEGED THAT THE KINK CAUSED THE PATIENT TO RETAIN URINE, AS THE PATIENT WAS UNABLE TO VOID. ALLEGEDLY, THE PATIENT'S BLADDER WAS SCANNED AND 400CC OF URINE REMAINED. IT WAS ALLEGED THAT ONCE THE TUBING WAS MANIPULATED, 425CC OF URINE DRAINED FROM THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: Urinary Retention

  MAUDE report 7046656 ↗