Bard® Silastic® Foley Catheter 33614Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741020056), received between Mar 12, 2018 and Aug 15, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Unclear Information” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN CUSTOMER WAS RECEIVED 2 BOXES OF 10 PIECES FOLEY CATHETER, BUT IN ONE OF THE BOX CAME ONLY THE PACKAGING AND IT DID NOT HAD CATHETER INSIDE IT, IN TOTAL 19 PIECES OF THAT CATHETER WERE RECEIVED, THERE WAS ONLY ONE PIECE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814752 ↗
• MalfunctionApr 8, 2024Unclear Information; Unclear Information

  IT WAS REPORTED THE ITEM WAS SUPPOSED TO BE A 14FR 5CC 2 WAY, SILASTIC FOLEY CATHETER. THE PACKAGE WAS LABELED AS SUCH, BUT THE PRODUCT ITSELF WAS LABELED AS A 10ML CATHETER. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 27MAR2024, IT WAS REPORTED THAT THE THREE DIFFERENT LOTS WERE PROVIDED NGGR4541, NGGS0282 AND NGGR4535.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060375 ↗
• MalfunctionJan 10, 2024Unclear Information; Unclear Information

  IT WAS REPORTED THAT THE CUSTOMER ORDERED 5CC 14FR SILASTIC FOLEY CATHETERS AND THEY WERE LABELLED ON THE PACKAGE AS 14 FR. 5CC RIBBED BALLOON SILASTIC, BUT THE ACTUAL CATHETER WAS LABELLED 10 ML. THIS DID NOT WORK FOR THE PATIENT. COULD GOT THE CORRECTED ITEMS AND RETURNED THE INCORRECT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18485945 ↗
• MalfunctionOct 5, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THERE WERE TWO FAULTY CATHETERS IN WHICH THE WATER TO INFLATE THE FOLEY CATHETER BALLOON, HAD NOT STAYED IN AND LEAKED OUT. ONE HAPPENED STRAIGHT AWAY AND OTHER SOME TIME HAD PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576273 ↗
• MalfunctionJul 7, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT 2 OF THE LAST 3 FOLEY CATHETERS DID NOT DRAIN EVEN THOUGH THERE WAS NO SEDIMENT OR ANYTHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12128771 ↗
• MalfunctionMar 12, 2018Device Contamination with Chemical or Other Material; Material Discolored; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLACK SPOTS WERE PRESENT IN THE PRODUCT.

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

  MAUDE report 7330322 ↗