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Bard® Foley Tray with Bardex® All Silicone Foley Catheter 897214Recalls & reported problems

C. R. Bard, Inc. · Bard® Foley Tray with Bardex® All Silicone Foley Catheter · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741020315), received between Oct 3, 2017 and Mar 16, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Component Missing1
  • Deflation Problem1
  • Device Inoperable1
  • Difficult to Remove1
  • Material Rupture1

Patient problems

  • No Known Impact Or Consequence To Patient3
  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMar 16, 2022Component Missing; Component Missing

    IT WAS REPORTED THAT THE CUSTOMER WAS OPENING THE BOXES OF FOLEY KITS TO PUT THEM IN DRAWERS AND FOUND ONE BOX WAS SHORT TWO. STATED THAT ONE BOX OF FOLEY KIT HAD TEN AND BOTTOM ONE OF FOLEY KIT HAD 8 AND IT WAS SENT IN THE BARD BOX MISSING TWO EACH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13777523 ↗
  • MalfunctionJul 3, 2019Difficult to Remove; Deflation Problem; Difficult to Remove

    IT WAS REPORTED THAT THE BALLOON OF THE SILICONE CATHETER WOULD NOT DEFLATE. THE CATHETER WAS REMOVED WITH THE BALLOON STILL INFLATED. NO PATIENT INJURY WAS REPORTED. ALL GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN COMPLETED.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 8760673 ↗
  • MalfunctionNov 14, 2017Material Rupture

    IT WAS REPORTED THAT THE CATHETER BALLOON BURST AFTER BEING INFLATED WITH 10CC OF WATER DURING A TRAINING (PRETEST). ALLEGEDLY, NO PIECES WERE REPORTED MISSING AND THE CATHETER WAS LAYING ON A TABLE WHEN THE BALLOON BURST.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7029195 ↗
  • MalfunctionOct 3, 2017Device Inoperable

    IT WAS REPORTED THAT THE CATHETER BALLOON FAILED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6911019 ↗

Other CATHETER, URETHRAL devices

All CATHETER, URETHRAL devices →

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