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SureStep™ Foley Tray System with Bard® Lubri-Sil® Catheter A942212Recalls & reported problems

C. R. Bard, Inc. · SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray 350 ml Urine Meter · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741100536), received between Sep 29, 2022 and Sep 29, 2022 — 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 25, 2026Open, 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 · FDA record ↗

Most reported problems

Device problems

  • Material Puncture/Hole1

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.

  • MalfunctionSep 29, 2022Material Puncture/Hole; Material Puncture/Hole

    IT WAS REPORTED THAT WHEN REGISTERED NURSE INSERTED THE FOLEY CATHETER AND INFLATED THE BALLOON, THE FLUID LEAKED OUT OF INSERTION SITE AND THE CATHETER BECAME DISLODGED. STATED THAT WHEN ASSESSED THE PRODUCT REGISTERED NURSE NOTED THAT BALLOON HAD A LEAK. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 16SEP2022, STATED THAT THERE WAS NO INJURY TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15504811 ↗

Other CATHETER, RETENTION TYPE, BALLOON devices

All CATHETER, RETENTION TYPE, BALLOON devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.