Bard® Silastic® Foley Catheter 33618Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00801741020070), received between Aug 24, 2017 and Apr 29, 2026 — classified as 6 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (8 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE LATEX FOLEY CATHETER WAS NOT DRAINING URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037944 ↗
• MalfunctionMar 2, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CLIENT HAD COMPLAINED OF A MANUFACTURING DEFECT OR PRODUCT ISSUE INVOLVING THE CATHETER BALLOON. HE HAD STATED THAT HE WAS ABLE TO INFLATE THE BALLOON; HOWEVER, URINE DID NOT FLOW. THE CATHETER HAD NOT BEEN OBSTRUCTED OR BLOCKED. HE SUSPECTED THAT THE BALLOON HAD BEEN PUTTING PRESSURE ON THE AREA THAT ALLOWS URINE TO DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483446 ↗
• MalfunctionFeb 25, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CLIENT HAD COMPLAINED OF A MANUFACTURING DEFECT OR PRODUCT ISSUE INVOLVING THE BALLOON. HE STATED THAT HE HAD BEEN ABLE TO INFLATE THE BALLOON, BUT URINE HAD NOT FLOWED. HE NOTED THAT THE CATHETER HAD NOT BEEN OBSTRUCTED OR BLOCKED. HE SUSPECTED THAT THE BALLOON HAD BEEN APPLYING PRESSURE ON THE AREA THROUGH WHICH URINE WOULD NORMALLY DRAIN, THEREBY PREVENTING PROPER FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444450 ↗
• InjuryDec 12, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY THE CUSTOMER STATED THE CATHETER (B)(6) 2025 - THE BALLOON WOULD NOT DEFLATE. THE DOCTOR HAD TO CLOSE OFF THE LINE AND LET THE BALLOON DEFLATE FOR 2 HOURS. AND THE CATHETER (B)(6) 2025 ¿ THE BALLON WOULD NOT DEFLATE. SO, THE DOCTOR USED A SURGICAL INSTRUMENT TO REMOVE THE CATHETER WITH THE BUBBLE INFLATED.

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

  MAUDE report 23796665 ↗
• MalfunctionOct 15, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETERS WOULD NOT DRAIN THE PATIENT HAD TO GO TO THE HOSPITAL TO GET IT REPLACED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07OCT2025, IT WAS REPORTED THAT THE CATHETER WAS REMOVED. CATHETER (SUPRA PUBIC) WAS PLACED ON (B)(6) 2025. IT WORKED ON FRIDAY, HOWEVER ON SATURDAY IT WOULD NOT DRAIN. CUSTOMER WENT TO THE EMERGENCY ROOM THAT AFTERNOON AND THEY DID SOME TROUBLESHOOTING. THEY TRIED FLUSHING AND OTHER STUFF, BUT NOTHING CHANGED THE PROBLEM. CUSTOMER PROVIDED THEM WITH ANOTHER CATHETER OF A DIFFERENT LOT NUMBER AND THEY REPLACED IT. EVERYTHING WORKED FINE AFTER THAT. CUSTOMER WOULD LIKE TO NOTE THAT THIS WAS THE SECOND CATHETER FROM THE SAME LOT NUMBER THAT FAILED IN THE SAME MANNER. CUSTOMER HAD PURCHASED 20 OF THESE CATHETERS FROM BUYMEDICAL.COM. THE REMAINING CATHETERS WERE RETURNED TO THEM AND MY MONEY WAS REFUNDED FOR THE RETURNED UN- USED ONES. CUSTOMER NOTED THAT LOT NUMBER WAS MANUFACTURED IN MALASYA AND THE ONES I HAD NO PROBLEM WITH WERE MADE IN THE USA. THEY EXCLUSIVELY USE THE BARD SILASTIC CATHETER. THE PROBLEM THEY HAVE NOW IS WHERE TO PURCHASE THEM AND NOT HAVE THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289775 ↗
• MalfunctionOct 6, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT UNABLE TO DEFLATE THE BALLOON ONCE THE FOLEY CATHETER WAS NEEDED TO BE REPLACED. NO FLUID WAS ABLE TO BE PULLED INTO THE SYRINGE TO DEFLATE THE BALLOON. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 22DEC2025 LAST REPORT THEY HAD NOT HAD ANY PATIENT HARM WITH THE CATHETER UNTIL (B)(6) 2025 THAT WAS THE NOTIFICATION FROM THE STAFF NURSE HAD TO SEND THEM TO THE EMERGENCY ROOM FOR ONE OF THE DEFECTIVE CATHETERS. 18 FR.10 CC SILASTIC LOT NGKV2072. TRIED EVERYTHING POSSIBLE AND TRIED FOR 2 HOURS AND BALLOON WOULD NOT DEFLATE. EMERGENCY DEPARTMENT PROVIDED REPORT AND FOLEY CATHETER PLACED THROUGH URETHRA TO PROVIDE PATIENT WITH RELIEF FROM BLADDER FILLING. THEY HAD ASKED THE NURSES TO INCLUDE THE LOT NUMBER OF ALL THE CATHETERS THEY WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23222987 ↗
• MalfunctionOct 1, 2025Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material

  IT WAS REPORTED THAT THE HOSPITAL USER OPENED MULTIPLE CATHETERS AND THESE LOT# ARE REF#33618, LOT #NGJX4260, REF#33420, LOT# NGJZ0361, LOT#NGJX3010. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 25SEP2025, IT WAS REPORTED THAT THE CUSTOMER RECEIVED THE EMAIL 8/14/25 ¿THE COMPLAINT INDICATES THAT A PHOTO SAMPLE HAS BEEN PROVIDED THEREFORE A PHYSICAL SAMPLE IS NOT NEEDED.¿ ALSO, EXCESS POWDER AND CRUMB CAN¿T BE SEEN NOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23190797 ↗
• MalfunctionSep 16, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE BARD SILASTIC 18 AND 20 FRENCH FOLEY CATHETERS - RECURRENCE INCIDENTS OF DRAINAGE ISSUES ASSOCIATED WITH THESE CATHETERS IN POST-RADICAL PROSTATECTOMIES PATIENTS. CATHETER STOPPED DRAINING AS INTENDED. IT WAS REPORTED THAT THE GIVEN LOT# WAS NGJX5831.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065197 ↗
• MalfunctionSep 11, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETERS WOULD NOT DRAIN THE PATIENT HAD TO GO TO THE HOSPITAL TO GET IT REPLACED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07OCT2025, IT WAS REPORTED THAT THE CATHETER WAS REMOVED. CATHETER (SUPRA PUBIC) WAS PLACED ON (B)(6) 2025. IT WORKED ON FRIDAY, HOWEVER ON SATURDAY IT WOULD NOT DRAIN. CUSTOMER WENT TO THE EMERGENCY ROOM THAT AFTERNOON AND THEY DID SOME TROUBLESHOOTING. THEY TRIED FLUSHING AND OTHER STUFF, BUT NOTHING CHANGED THE PROBLEM. CUSTOMER PROVIDED THEM WITH AN OTHER CATHETER OF A DIFFERENT LOT NUMBER AND THEY REPLACED IT. EVERYTHING WORKED FINE AFTER THAT. CUSTOMER WOULD LIKE TO NOTE THAT THIS WAS THE SECOND CATHETER FROM THE SAME LOT NUMBER THAT FAILED IN THE SAME MANNER. (B)(4). CUSTOMER HAD PURCHASED 20 OF THESE CATHETERS FROM BUYMEDICAL.COM. THE REMAINING CATHETERS WERE RETURNED TO THEM AND MY MONEY WAS REFUNDED FOR THE RETURNED UN- USED ONES. CUSTOMER NOTED THE THAT LOT NUMBER WAS MANUFACTURED IN MALASYA AND THE ONES I HAD NO PROBLEM WITH WERE MADE IN THE USA. THEY EXCLUSIVELY USE THE BARD SILASTIC CATHETER. THE PROBLEM THEY HAVE NOW IS WHERE TO PURCHASE THEM AND NOT HAVE THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031994 ↗
• InjurySep 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT SILASTIC 18 FR AND 20 FR FOLEY CATHETERS WERE HAVING ISSUES. NO MEDICAL INTERVENTION AND NO PATIENT INJURY WAS REPORTED. PCN#(B)(6) AND PCN#(B)(6). PER ADDITIONAL INFORMATION RECEIVED ON 04SEP2025, CUSTOMER HIGHLIGHTED THE SERIOUSNESS OF THE ISSUE, NOTING THAT BALLOON INFLATION DURING FOLEY CATHETER PLACEMENT POST-RADICAL PROSTATECTOMY CAN OBSTRUCT URINE OUTFLOW, AFFECTING MULTIPLE PATIENTS. CUSTOMER ALSO STATED THAT ER VISITS AND CATHETER REPLACEMENTS DUE TO MALFUNCTION QUALIFY AS INJURIES.

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

  MAUDE report 23027396 ↗
• MalfunctionSep 10, 2025No Flow; Therapeutic or Diagnostic Output Failure

  BARD SILASTIC 18 AND 20 FRENCH FOLEY CATHETERS - RECURRENCE INCIDENTS OF DRAINAGE ISSUES ASSOCIATED WITH THESE CATHETERS IN POST-RADICAL PROSTATECTOMIES PATIENTS. CATHER STOPPED DRAINING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014895 ↗
• InjuryAug 22, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE CUSTOMER HAD RASH PROBLEMS WITH SILASTIC CATHETERS BECOMING OBSTRUCTED AND CAUSING LOTS OF PATIENT DIFFICULTY. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 22874283 ↗
• MalfunctionAug 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SILASTIC FOLEY CATHETERS HAD EXCESS POWDER LOOK MATERIAL AROUND FOLEY CONNECTER AREA, AND YELLOW DISCOLORED SUBSTANCE AROUND FOLEY CATHETER HOLE AREA. MULTIPLE FOLEY CATHETER PACKAGES WERE OPENED TO FIND ACCEPTABLE CATHETER. DOCTOR DECIDED TO USE LATEX FREE CATHETERS FOR THEIR PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874269 ↗
• MalfunctionAug 19, 2025Contamination; Material Discolored

  SPECIFIC EVENT TYPE: SUPPLY ISSUE. PERSON AFFECTED: NOT ASSOCIATED WITH A PERSON. SEVERITY LEVEL: GOOD CATCH. INJURY INCURRED? NO. EQUIPMENT/PRODUCT INVOLVED/MALFUNCTIONED? YES. BRIEF FACTUAL DESCRIPTION: SILASTIC FOLEY CATHETERS HAVE EXCESS POWDER LOOK MATERIAL AROUND FOLEY CONNECTER AREA, AND YELLOW DISCOLORED SUBSTANCE AROUND FOLEY CATHETER HOLE AREA. MULTIPLE FOLEY CATHETER PACKAGES ARE OPENED TO FIND ACCEPTABLE CATHETER. DOCTOR DECIDED TO USE LATEX FREE CATHETERS FOR HIS PROCEDURES. CONTRIBUTING FACTORS (REPORTED): NONE/UNKNOWN. IMMEDIATE ACTIONS (REPORTED); USED LATEX FREE FOLEY CATHETER. MANUFACTURER RESPONSE FOR CATHETER, RETENTION TYPE, BALLOON, BARD® SILASTIC® FOLEY CATHETER (PER SITE REPORTER). OR SERVICE LEADER CALLED OUR BARD REP. [DATE REDACTED] AND IS WAITING FOR RETURN PHONE CALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838336 ↗
• InjuryAug 14, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT FOLEY CATHETER WAS UNABLE TO DEFLATE THE BULB VIA NORMAL MEANS. IT REQUIRED ADDITIONAL INTERVENTION BY SPECIALIST. PATIENT WAS TRANSFERRED TO FACILITY WITH ON-CALL UROLOGIST FOR CYSTOSCOPY.

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

  MAUDE report 22805325 ↗
• MalfunctionAug 5, 2025Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT PRIOR TO JUNE 30TH, THE CUSTOMER RECEIVED A NEW SILASTIC 2-WAY SPECIALTY, SHORT ROUND TIP, TWO OPPOSING DRAINAGE EYES, AND EXPERIENCED EXTREME DIFFICULTY IN FLUSHING THE CATHETER, SOMETHING THAT NORMALLY TAKES NO TIME WAS TAKING SOME TIME WHICH WAS UNUSUAL, TO DRAW OUT THE STERILE WATER. ON JULY 28TH THE CUSTOMER WENT TO THE HOSPITAL, THE REGISTERED NURSE WANTED TO SEE WHAT WAS GOING ON. STERILE WATER WAS INJECTED TO FLUSH, HOWEVER, THE CATHETER BALLOONED AT THE STEM INSTEAD OF WHERE IT WAS SUPPOSED TO BALLOON. NO PATIENT HARM REPORTED. SAMPLE AVAILABLE. CUSTOMER WOULD LIKE FOLLOW UP ASAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715486 ↗
• MalfunctionAug 5, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT PRIOR TO (B)(6), THE CUSTOMER RECEIVED A NEW SILASTIC 2-WAY SPECIALTY, SHORT ROUND TIP, TWO OPPOSING DRAINAGE EYES, AND EXPERIENCED EXTREME DIFFICULTY IN FLUSHING THE CATHETER, SOMETHING THAT NORMALLY TAKES NO TIME WAS TAKING SOME TIME WHICH WAS UNUSUAL, TO DRAW OUT THE STERILE WATER. ON (B)(6) THE CUSTOMER WENT TO THE HOSPITAL, THE REGISTERED NURSE WANTED TO SEE WHAT WAS GOING ON. STERILE WATER WAS INJECTED TO FLUSH, HOWEVER, THE CATHETER BALLOONED AT THE STEM INSTEAD OF WHERE IT WAS SUPPOSED TO BALLOON. NO PATIENT HARM REPORTED. SAMPLE AVAILABLE. CUSTOMER WOULD LIKE FOLLOW UP ASAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714575 ↗
• MalfunctionJul 31, 2025Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT SILASTIC 18 FR AND 20 FR FOLEY CATHETERS WERE HAVING ISSUES. NO MEDICAL INTERVENTION AND NO PATIENT INJURY WAS REPORTED. PCN# (B)(6). PER ADDITIONAL INFORMATION RECEIVED ON 04SEP2025, CUSTOMER HIGHLIGHTED THE SERIOUSNESS OF THE ISSUE, NOTING THAT BALLOON INFLATION DURING FOLEY CATHETER PLACEMENT POST-RADICAL PROSTATECTOMY CAN OBSTRUCT URINE OUTFLOW, AFFECTING MULTIPLE PATIENTS. CUSTOMER ALSO STATED THAT ER VISITS AND CATHETER REPLACEMENTS DUE TO MALFUNCTION QUALIFY AS INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22678026 ↗
• MalfunctionJul 17, 2025Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE HOSPITAL USER OPENED MULTIPLE CATHETERS AND THESE LOT# ARE REF# (B)(4), LOT #NGJX4260. REF# (B)(4), LOT# NGJZ0361, LOT#NGJX3010.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535554 ↗
• MalfunctionJul 17, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WAS NOT DRAINING WELL OR ASPIRATING WHILE FOLEY CATHETER BALLOON WAS UP AND PATIENT CONCERNED PER THAT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531713 ↗
• MalfunctionJul 17, 2025Inaccurate Flow Rate; Inflation Problem; Inaccurate Flow Rate; Inflation Problem

  IT WAS REPORTED THAT WAS NOT DRAINING WELL OR ASPIRATING WHILE FOLEY CATHETER BALLOON WAS UP AND PATIENT WAS CONCERNED PER THAT ISSUE. PER ADDITIONAL INFORMATION RECEIVED ON 04SEP2025, CUSTOMER HIGHLIGHTED THE SERIOUSNESS OF THE ISSUE, NOTING THAT BALLOON INFLATION DURING FOLEY CATHETER PLACEMENT POST-RADICAL PROSTATECTOMY CAN OBSTRUCT URINE OUTFLOW, AFFECTING MULTIPLE PATIENTS. CUSTOMER ALSO STATED THAT ER VISITS AND CATHETER REPLACEMENTS DUE TO MALFUNCTION QUALIFY AS INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531710 ↗
• MalfunctionApr 30, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THEY HAD NOTICED SEVERAL PATIENTS REPORTED THEIR URINARY CATHETER STOPPED DRAINING. THE CATHETER FLUSHES EASILY WITHOUT OBSTRUCTION. THE FOLEY CATHETER WAS VERY SLOW TO DEFLATE, BUT ONCE DEFLATED, THE CATHETER DRAINS APPROPRIATELY. THAT SEEMED TO INDICATE THAT THE INTERNAL LUMEN OF THE CATHETER HAS BEEN AFFECTED BY THE BALLOON SOMEHOW. THEY WERE CONCERNED ABOUT A MANUFACTURING DEFECT. THAT WAS ONLY AFFECTING SIZE 18FR (REF # (B)(4), OF THE MOST RECENT SHIPMENT WE RECEIVED. THEY COULD ONLY VERIFY THE LOT NUMBER FROM A PATIENT THAT HAD TO HAVE THE CATHETER REMOVED AND CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935791 ↗
• MalfunctionDec 26, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER SAID THAT THE FOLEY BALLOON DID NOT DEFLATE AT THE TIME OF REMOVAL FOR A FOLEY EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018789 ↗
• MalfunctionAug 13, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE ACTUAL BALLOON OF FOLEY CATHETER WAS FAULTY. THE BALLOON DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972079 ↗
• MalfunctionJul 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BALLOON BURST EVENT WITH TWO OF THE SILASTIC 18FR 5CC CATHETERS THEY HAD USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643786 ↗