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SureStep™ Foley Tray System with Bard® All-Silicone Temp Sensing Catheter A119110Recalls & reported problems

C. R. Bard, Inc. · SureStep™ Foley Tray System Bard® All-Silicone Temperature Sensing Foley Catheter Tray 350 ml Urine Meter · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741100581), received between Jul 18, 2023 and Jul 18, 2023 — classified as 1 malfunction.

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

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.

Most reported problems

Device problems

  • Material Invagination1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJul 18, 2023Material Invagination; Material Invagination

    IT WAS REPORTED THAT THERE HAVE BEEN SOME PATIENTS THAT HAD A 10F OR 8FR INDWELLING CATHETER AND THE NURSE HAD DIFFICULTY REMOVING IT. APPARENTLY, THE BALLOON CAUSED A RIDGE AFTER BEING INFLATED AND MAKES IT UNREMOVABLE. THEY HAVE REINFLATED AND DELATED AND THIS SOMETIMES WORKS. THE CATHETERS CITED WERE A119108 AND A119110.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17341696 ↗

Other CATHETER, RETENTION TYPE, BALLOON devices

All CATHETER, RETENTION TYPE, BALLOON devices →

Sources and updates

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