SureStep™ Foley Tray System Bardex® Lubricath® Temperature Sensing Catheter A900216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741120978), received between Mar 30, 2023 and Mar 30, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

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-3114-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER MOVING PATIENT TO A BED IN THE POST-ANESTHESIA CARE UNIT, TEMPERATURE SENSING FOLEY CATHETER SLID OUT OF PATIENT WHEN NURSE WAS MOVING FOLEY BAG. IT WAS OBSERVED THAT THE BALLOON WAS NOT INFLATED AT THE END OF THE CASE. THE FOLEY BALLOON WAS INFLATED AT BEGINNING OF CASE BECAUSE THERE WAS URINE RETURN. THEY CHECKED THE FOLEY BALLOON TO SEE IF IT HAD A LEAK AND FOUND THAT THE BALLOON WAS INTACT BUT THE INJECTION PORT TO INFLATE THE BALLOON WAS LEAKING SLOWLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645481 ↗