SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A319516ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741100338), received between Jan 3, 2019 and Mar 24, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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-3115-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A HOLE IN ONE CASE OF SILICONE MONOPLUG INSERT SHEET AND METER BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13873750 ↗
• MalfunctionMar 21, 2022Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE CUSTOMER STARTED TO OPEN THE OUTER PACKAGE OF FOLEY TRAY ON (B)(6) 2022, A GOOD SIZE HOLE WAS NOTICED IN THE INSERT SHEET, BUT THE HOLE DID NOT APPEAR TO HAVE GONE BEYOND THE INSERT SHEET. IT WAS REPORTED THAT THIS TRAY WAS PLACED ON TOP OF 10 OF THE SAME TRAY KITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840428 ↗
• MalfunctionJan 3, 2019Break; Fluid/Blood Leak; Material Puncture/Hole; Break

  IT WAS REPORTED THAT, AFTER INSERTION, A PIN HOLE SIZE LEAK WAS NOTED IN THE FOLEY CATHETER NEAR THE LOCATION OF THE BIFURCATION. THIS RESULTED IN THE NEED TO REMOVE THE CATHETER AND CAUSED THE PATIENT PAIN. NO MEDICAL INTERVENTION WAS REQUIRED. AFTER EVALUATION OF THE SAMPLE, IT WAS FOUND THAT THERE WAS NO BALLOON DEFLATION OR LEAKS FROM THE INFLATION LUMEN. HOWEVER, THERE WAS A LEAK FROM A HOLE IN THE DRAINAGE LUMEN.

  Patient problems: Pain

  MAUDE report 8213730 ↗