Bard® Silastic® Foley Catheter 33424Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741020025), received between Apr 21, 2017 and Feb 19, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (4 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. Apr 23, 2026Class IIOpen, Classified

   Due to stain present on the surface of affected foley catheters.

   Z-2226-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Collapse; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE HAD DEMONSTRATED ABNORMAL INWARD BALLOON INFLATION, WHICH CAUSED THE DISTAL END OF THE CATHETER TO COLLAPSE, THEREBY OBSTRUCTING PROPER DRAINAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388498 ↗
• MalfunctionFeb 3, 2026Complete Blockage

  IT WAS REPORTED THAT THE CUSTOMER COULD NOT USE THE FOLEY CATHETER DUE TO THE BALLOON OCCLUDING THE CATHETER TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254715 ↗
• MalfunctionJun 19, 2020Failure to Infuse; Improper or Incorrect Procedure or Method; Failure to Infuse

  IT WAS REPORTED THAT THE INFLATION LUMEN WAS INFLATED INSTEAD OF THE BALLOON ON THE FOLEY CATHETER. IT WAS NOTED THAT THE SAME ISSUE OCCURRED WHEN IT WAS DEFLATED AND INFLATED AGAIN DURING FURTHER INSPECTION IT WAS FOUND THAT THE CATHETER HAD ALREADY PASSED THE EXPIRY DATE.

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

  MAUDE report 10174489 ↗
• MalfunctionJun 19, 2020Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE FOLEY CATHETER BALLOON WHICH RESULTED IN WATER LEAKING OUT.

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

  MAUDE report 10174341 ↗
• MalfunctionApr 8, 2020Complete Blockage; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT "THE BALLOON DID NOT WORK PROPERLY, LIKE THERE WAS A BLOCKAGE" AND IT WOULD NOT ACCEPT THE WATER FROM THE SYRINGE.

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

  MAUDE report 9938644 ↗
• MalfunctionSep 7, 2017Complete Blockage; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS CLOGGED, CAUSING IT TO LEAK. THE CATHETER WAS REMOVED AND REPLACED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6849913 ↗
• MalfunctionSep 7, 2017Leak/Splash

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING FROM THE MEATUS. THE CATHETER WAS REMOVED AND REPLACED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6849896 ↗
• MalfunctionSep 7, 2017Complete Blockage; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS CLOGGED CAUSING IT TO LEAK. THE CATHETER WAS REMOVED AND REPLACE WITHOUT FURTHER INCIDENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6849634 ↗
• MalfunctionApr 21, 2017Crack

  IT WAS REPORTED THAT THE RUBBER WAS CRACKING AROUND THE RUBBER TUBING OF THE INFLATION PORT.

  Patient problems: No Information

  MAUDE report 6511952 ↗