Bard® Silastic® Foley Catheter 33416Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741019982), received between Nov 10, 2017 and Feb 19, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT SILASTIC 2-WAY LATEX FOLEY CATHETER 16 FR 30 CC DID NOT DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393489 ↗
• InjuryFeb 12, 2026Complete Blockage

  PATIENT CALLED AND STATED THE CATHETER FAILED AND BLOCKED EVERYTHING IN. HE HAD TO GO TO THE HOSPITAL TO HAVE IT REMOVED. HE STATED THEY REPLACED THE CATHETER FOR HIM. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24328070 ↗
• MalfunctionDec 2, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER HAD A CASE WHERE THE FOLEY BALLOON DEFLATED AND THE PROBE CAME LOOSE. IT WAS THE SECOND BOX WITH THIS PROBLEM FOR THE SAME CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694120 ↗
• MalfunctionAug 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER TUBE HAD ALREADY BEEN PLACED IN THE PATIENT BUT ONLY WORKED FOR ABOUT AN HOUR. THEY MENTION THAT THIS BALLOON ONLY INFLATED TO 18ML, AND IT BROKE. FORTUNATELY, IT DID NOT CAUSE ANY HARM TO THE PATIENT. PER POTENTIAL FOLLOW UP INFORMATION RECEIVED VIA IBC ON 29AUG2025, STATED THAT THERE WAS NO MEDICAL INTERVENTION NEEDED. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 29AUG2025, STATED THAT THERE WAS DISCOMFORT BECAUSE IT WAS ALREADY IN PLACE AND HAD TO BE REMOVED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905089 ↗
• MalfunctionJul 7, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE FOLEY CATHETER PROBE DID NOT HAVE THE CAP WHERE THE FR AND GLOBE INDICATES. IN ADDITION, THE PROBE HAS A WHITE COLOR INSIDE. THE PRODUCT WAS NO LONGER USED. FORTUNATELY, IT WAS DETECTED IN TIME, BUT IT COULD DIRECTLY AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414325 ↗
• MalfunctionJul 7, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER PROBE DID NOT HAVE THE CAP WHERE THE FR AND GLOBE INDICATE. IN ADDITION, THE PROBE HAS A WHITE COLOR INSIDE. THE PRODUCT WAS NO LONGER USED. FORTUNATELY, IT WAS DETECTED IN TIME, BUT IT COULD DIRECTLY AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414317 ↗
• MalfunctionJun 19, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT WHEN THE PATIENT USED THE FOLEY CATHETER IT DID NOT FLOW THROUGH, AND IT WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293132 ↗
• MalfunctionApr 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT FOLEY CATHETER WAS IN PATIENT AFTER INSERTION DATE OF (B)(6) 2025 FOLEY CATHETER FELL OUT WHEN STAFF LOOKED AT FOLEY THE BALLOON LOCKED SLICED AND HAD LARGE HOLE. IT WAS NOTED THAT THE GIVEN LOT# WAS NGJT0052. NEW FOLEY INSERTED BUT SECOND TIME THIS HAS HAPPENED TO US WITH THE 16FR 30CC RIBBED BALLON SILASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785123 ↗
• MalfunctionApr 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT FOLEY CATHETER WAS IN PATIENT AFTER INSERTION DATE OF (B)(6) 2025 FOLEY CATHETER FELL OUT WHEN STAFF LOOKED AT FOLEY THE BALLOON LOCKED SLICED AND HAD LARGE HOLE. IT WAS NOTED THAT THE GIVEN LOT # WAS NGJT0052. NEW FOLEY INSERTED BUT SECOND TIME THIS HAS HAPPENED TO US WITH THE 16FR 30CC RIBBED BALLOON SILASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761543 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION. PER CUSTOMER ON (B)(6)2024, IT WAS REPORTED THAT SHE EXPERIENCED A URINARY TRACT INFECTION AND WAS PRESCRIBED ANTIBIOTICS FOR IT. CUSTOMER STATED HER DOCTOR ORDERED FOR THE CATHETER TO BE REPLACED MORE FREQUENTLY.

  Patient problems: Urinary Tract Infection

  MAUDE report 18702038 ↗
• MalfunctionJul 20, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED, THAT THE CUSTOMER WAS SLEEPING IN BED. AND UPON AWAKENING HAD FOUND THE FOLEY CATHETER LYING BESIDE THEM. THE CUSTOMER EXAMINED THE CATHETER AND FOUND THE BALLOON HAD RUPTURED. THE CUSTOMER THEN PHONED THE HOME CARE OFFICE FIRST THING IN THE MORNING, AND REQUESTED TO COME IN AND HAD SAME REINSERTED. AS WAS UNABLE TO VOID. THE OLD CATHETER WAS EXAMINED, AND THE RUPTURED BALLOON APPEARS TO BE ONE UNIT, NO MISSING PIECES NOTED. NO APPARENT HARM REACHED THE PATIENT. THE IMPACT OF THE INCIDENT WAS PATIENT WAS UNABLE TO VOID. THE PATIENT REQUIRED UNEXPECTED OR PROLONGED CARE.

  Patient problems: Urinary Retention

  MAUDE report 17364148 ↗
• MalfunctionJan 23, 2019Incorrect Measurement; Material Puncture/Hole; Material Integrity Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY LONGER THAN NORMAL, WITH HOLES IN DIFFERENT SPOTS. ALLEGEDLY, THE LONGER LENGTH IN CATHETER CAUSED SEVERE BLEEDING AFTER BEING IN SITU FOR ABOUT 10 DAYS. THE PATIENT APPARENTLY CALLED THE NURSE WHO ADVISED HOSPITAL ASSESSMENT, BUT THE PATIENT OPTED TO WAIT UNTIL THE MORNING TO VISIT HIS/HER DOCTOR WHO ALLEGEDLY CHANGED THE BLOOD THINNER MEDICATION TO HELP LIMIT THE BLEEDING. IT WAS LATER NOTED THAT THE BLEEDING SLOWED BUT DIDN¿T STOP UNTIL A WEEK AFTER THE INITIAL CONVERSATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 8270604 ↗
• MalfunctionNov 29, 2018Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT ON 09NOV2018 A BD ASSOCIATE RECEIVED A CALL FROM THE CUSTOMER STATING THAT THREE FOLEY CATHETERS WERE UNABLE TO INFLATE WITH THE STERILE WATER. HE NOTED THAT WHEN HE ATTEMPTED TO INFLATE THE DEVICE, THE SHAFT WAS BLOWN UP BUT THE BALLOON ITSELF DID NOT. THIS EVENT OCCURRED PRIOR TO USE. A BUBBLE FORMED AT THE POINT OF THE SYRINGE. THE WATER WENT INTO THE FIRST PART OF THE CATHETER SHAFT BUT NO FURTHER. NO OBSTRUCTIONS COULD BE SEEN IN THE TUBING. THE USER WAS EXPERIENCED.

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

  MAUDE report 8118477 ↗
• MalfunctionNov 10, 2017Deflation Problem

  IT WAS REPORTED THAT THE NURSE WAS UNABLE TO DEFLATE THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7022695 ↗
• MalfunctionNov 10, 2017Deflation Problem

  IT WAS REPORTED THAT THE NURSE WAS UNABLE TO DEFLATE THE BALLOON. PER ADDITIONAL INFORMATION, THE NURSE WENT TO THE CLIENT'S HOUSE FOR A BIWEEKLY CATHETER CHANGE. THE CATHETER WAS CUT BELOW THE VALVE BUT THE BALLOON SUPPOSEDLY WOULD NOT DEFLATE. THE PATIENT HAD TO BE SENT TO SHUSWAP LAKE GENERAL HOSPITAL'S EMERGENCY ROOM BUT THE CATHETER BALLOON STILL COULD NOT BE DEFLATED AND CLIENT WAS SENT HOME. THE FOLLOWING DAY, THE CLIENT WENT BY AMBULANCE TO VERNON JUBILEE HOSPITAL AND AFTER SEEING 3 DIFFERENT DOCTORS THE BALLOON WAS MANUALLY DEFLATED, AND A NEW CATHETER WAS INSERTED. THE CLIENT IS NOW REFUSING TO USE THIS PRODUCT AGAIN AS THIS IS THE 3RD TIME THIS HAS OCCURRED WITH THIS BRAND/TYPE AND SIZE OF BARD CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7022617 ↗
• MalfunctionNov 10, 2017Deflation Problem

  IT WAS REPORTED THAT THE NURSE WAS UNABLE TO DEFLATE THE BALLOON. PER ADDITIONAL INFORMATION, THE NURSE WENT TO THE CLIENT'S HOUSE FOR A BIWEEKLY CATHETER CHANGE. THE CATHETER WAS CUT BELOW THE VALVE BUT THE BALLOON SUPPOSEDLY WOULD NOT DEFLATE. THE PATIENT HAD TO BE SENT TO (B)(6) HOSPITAL'S EMERGENCY ROOM BUT THE CATHETER BALLOON STILL COULD NOT BE DEFLATED AND CLIENT WAS SENT HOME. THE FOLLOWING DAY, THE CLIENT WENT BY AMBULANCE TO (B)(6) HOSPITAL AND AFTER SEEING 3 DIFFERENT DOCTORS THE BALLOON WAS MANUALLY DEFLATED, AND A NEW CATHETER WAS INSERTED. THE CLIENT IS NOW REFUSING TO USE THIS PRODUCT AGAIN AS THIS IS THE 3RD TIME THIS HAS OCCURRED WITH THIS BRAND/TYPE AND SIZE OF BARD CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7020492 ↗