Bard Silastic Foley CatheterRecalls & reported problems across all models

We found 13 models of Bard Silastic Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 234 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2017 and Jun 8, 2026 — classified as 36 injuries, 198 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (36 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Bard Silastic Foley Catheter recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 23, 2026Open, Classified

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

   Z-2226-2026 · Root cause: Material/Component Contamination · names 11 of these models · Recall details · FDA record ↗

Most reported Bard Silastic Foley Catheter problems

Bard Silastic Foley Catheter models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bard® Silastic® Foley Catheter 33620

  CATHETER, RETENTION TYPE, BALLOON
  1 recall50 reports
• Bard® Silastic® Foley Catheter 33618

  CATHETER, RETENTION TYPE, BALLOON
  1 recall39 reports
• Bard® Silastic® Foley Catheter 33616

  CATHETER, RETENTION TYPE, BALLOON
  1 recall30 reports
• Bard® Silastic® Foley Catheter 33420

  CATHETER, RETENTION TYPE, BALLOON
  1 recall26 reports
• Bard® Silastic® Foley Catheter 33624

  CATHETER, RETENTION TYPE, BALLOON
  1 recall25 reports
• Bard® Silastic® Foley Catheter 33416

  CATHETER, RETENTION TYPE, BALLOON
  1 recall16 reports
• Bard® Silastic® Foley Catheter 33418

  CATHETER, RETENTION TYPE, BALLOON
  1 recall11 reports
• Bard® Silastic® Foley Catheter 33422

  CATHETER, RETENTION TYPE, BALLOON
  1 recall11 reports
• Bard® Silastic® Foley Catheter 33424

  CATHETER, RETENTION TYPE, BALLOON
  1 recall9 reports
• Bard® Silastic® Foley Catheter 33622

  CATHETER, RETENTION TYPE, BALLOON
  1 recall7 reports
• Bard® Silastic® Foley Catheter 33614

  CATHETER, RETENTION TYPE, BALLOON
  1 recall6 reports
• Bard® Silastic® Foley Catheter 33426

  CATHETER, RETENTION TYPE, BALLOON
  2 reports
• Bard® Silastic® Foley Catheter 33428

  CATHETER, RETENTION TYPE, BALLOON
  2 reports

Recent Bard Silastic Foley Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE FOLEYS HE RECEIVED IN THIS ORDER WERE DAMAGED, CAUSING LEAKAGE. HE ALREADY USED 2 OUT OF THE 3. SENT AN EMAIL TO HAVE CUSTOMER SERVICE CALL BACK. NO ADDITIONAL INFORMATION PROVIDED. IT'S UNCLEAR IF TROUBLESHOOTING WAS PROVIDED. (PREPPING AND PLACEMENT TIPS SHARED)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437691 ↗
• MalfunctionMay 21, 2026Complete Blockage

  IT WAS REPORTED THAT CUSTOMER STATED FOLEY CATHETERS CLOGGED REALLY FAST AND LEAKED EVERYWHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250175 ↗
• 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 ↗
• MalfunctionApr 13, 2026Inaccurate Flow Rate

  IT WAS REPORTED BY THE CUSTOMER THAT TWO CATHETERS RECEIVED FROM THE ALBERTA AIDS TO DAILY LIVING PHARMACY FAILED TO DRAIN AS INTENDED. AS A RESULT, THE PATIENT EXPERIENCED BLADDER SPASMS AND URINE BYPASSING, WHICH NECESSITATED CATHETER REPLACEMENT. THE FIRST CATHETER INSERTION OCCURRED ON MONDAY MORNING, AND A SECOND CATHETER WAS INSERTED MONDAY EVENING DUE TO CONTINUED FAILURE TO DRAIN. A THIRD CATHETER INSERTION OCCURRED ON TUESDAY AFTERNOON USING HOME CARE STOCK, AT WHICH TIME MORE THAN 1,600 MILLILITERS OF URINE DRAINED WITHIN TWO HOURS. THE PRODUCT INVOLVED WAS A SILASTIC FOLEY CATHETER, 18 FRENCH, WITH A 30-CC RIBBED BALLOON MADE OF SILASTIC MATERIAL.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 24861204 ↗
• MalfunctionApr 8, 2026Inaccurate Flow Rate

  IT WAS REPORTED BY CUSTOMER THAT TWO CATHETERS RECEIVED FROM ALBERTA AIDS TO DAILY LIVING PHARMACY FAILED TO DRAIN AS INTENDED, WHICH RESULTED IN BLADDER SPASMS, URINE BYPASSING, AND CATHETER REPLACEMENT FOR THE PATIENT. THE FIRST CATHETER INSERTION OCCURRED ON MONDAY MORNING AND THE SECOND CATHETER INSERTION OCCURRED ON MONDAY EVENING DUE TO CONTINUED FAILURE TO DRAIN. A THIRD CATHETER INSERTION OCCURRED ON TUESDAY AFTERNOON USING HOME CARE STOCK, AND MORE THAN ONE THOUSAND SIX HUNDRED MILLILITERS OF URINE DRAINED WITHIN TWO HOURS. THE PRODUCT INVOLVED WAS SILASTIC FOLEY CATHETER EIGHTEEN FRENCH WITH THIRTY CUBIC CENTIMETER RIBBED BALLOON MADE OF SILASTIC MATERIAL.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 24819089 ↗
• InjuryMar 18, 2026Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER BEEN REPORTED AS DEFECTIVE, ACCORDING TO THE PATIENT THE BALLOON BURST INSIDE AND HAS TO BE HOSPITALIZED FOR 5 MONTHS, ANOTHER INSTANCE WAS THE BALLOON WAS LEFT INSIDE. THEY SEEK MEDICAL ATTENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24628320 ↗
• MalfunctionMar 12, 2026Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THERE WERE PROBLEMS REMOVING THE FOLEY CATHETER, AND HE STATED THAT HE WAS UNABLE TO WITHDRAW THE WATER FROM THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586386 ↗
• InjuryMar 4, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT BOTH OF THEIR ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMY PATIENTS FROM (B)(6) 2026 HAD NOW PRESENTED WITH FOLEY CATHETER MALFUNCTIONS. THE PATIENT FROM (B)(6) 2026 CAME TO THE EMERGENCY DEPARTMENT ON (B)(6) 2026 REPORTED SEVERAL HOURS WITHOUT URINE OUTPUT THROUGH THE CATHETER AND OVERFLOW INCONTINENCE AROUND IT. IN THE EMERGENCY DEPARTMENT, THE CATHETER COULD BE FORWARD FLUSHED BUT NOT ASPIRATED. WHEN THEY ATTEMPTED TO CHANGE THE CATHETER AND DEFLATED THE BALLOON, URINE BEGAN FLOWING, BUT ASPIRATION WAS STILL NOT POSSIBLE. AFTER REMOVED THE CATHETER, THEY CONFIRMED THE BALLOON WAS INTACT, THOUGH IT WAS VERY DIFFICULT TO DEFLATE AND THE BALLOON PORT COLLAPSED, COMPLICATING DEFLATION. WITH SLOW, STEADY TRACTION ON THE SYRINGE, THEY WAS EVENTUALLY ABLE TO COMPLETELY DEFLATE IT AND REPLACE THE CATHETER. THE SECOND PATIENT, FROM (B)(6) 2026, PRESENTED TO THE CLINIC ON (B)(6) 2026 WITH THE SAME COMPLAINT THEIR CATHETER ALSO FLUSHED EASILY BUT COULD NOT ASPIRATE. REPLACEMENT WAS SIMILARLY DIFFICULT DUE TO RESISTANCE DURING BALLOON DEFLATION, THOUGH DEFLATION WAS ULTIMATELY ACHIEVABLE. AFTER REMOVAL, THE CATHETER FLUSHED WELL BUT STILL DID NOT ASPIRATE UNTIL AFTER THE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513018 ↗
• MalfunctionMar 4, 2026Difficult to Remove

  IT WAS REPORTED THAT BOTH OF THEIR ROBOTIC-ASSISTED LAPAROSCOPIC PROSTATECTOMY PATIENTS FROM (B)(6) 2026 HAD NOW PRESENTED WITH FOLEY CATHETER MALFUNCTIONS. THE PATIENT FROM (B)(6) 2026 CAME TO THE EMERGENCY DEPARTMENT ON (B)(6) 2026 REPORTED SEVERAL HOURS WITHOUT URINE OUTPUT THROUGH THE CATHETER AND OVERFLOW INCONTINENCE AROUND IT. IN THE EMERGENCY DEPARTMENT, THE CATHETER COULD BE FORWARD FLUSHED BUT NOT ASPIRATED. WHEN THEY ATTEMPTED TO CHANGE THE CATHETER AND DEFLATED THE BALLOON, URINE BEGAN FLOWING, BUT ASPIRATION WAS STILL NOT POSSIBLE. AFTER REMOVED THE CATHETER, THEY CONFIRMED THE BALLOON WAS INTACT, THOUGH IT WAS VERY DIFFICULT TO DEFLATE AND THE BALLOON PORT COLLAPSED, COMPLICATING DEFLATION. WITH SLOW, STEADY TRACTION ON THE SYRINGE, THEY WAS EVENTUALLY ABLE TO COMPLETELY DEFLATE IT AND REPLACE THE CATHETER. THE SECOND PATIENT, FROM (B)(6) 2026, PRESENTED TO THE CLINIC ON (B)(6) 2026 WITH THE SAME COMPLAINT THEIR CATHETER ALSO FLUSHED EASILY BUT COULD NOT ASPIRATE. REPLACEMENT WAS SIMILARLY DIFFICULT DUE TO RESISTANCE DURING BALLOON DEFLATION, THOUGH DEFLATION WAS ULTIMATELY ACHIEVABLE. AFTER REMOVAL, THE CATHETER FLUSHED WELL BUT STILL DID NOT ASPIRATE UNTIL AFTER THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512892 ↗
• MalfunctionMar 4, 2026Collapse; Inability to Irrigate

  IT WAS REPORTED THAT BOTH OF THEIR ROBOTIC-ASSISTED LAPAROSCOPIC PROSTATECTOMY PATIENTS FROM (B)(6) 2026 AND (B)(6) 2026 HAD NOW PRESENTED WITH FOLEY CATHETER MALFUNCTIONS. THE PATIENT FROM (B)(6) 2026 CAME TO THE EMERGENCY DEPARTMENT ON (B)(6) 2026 REPORTED SEVERAL HOURS WITHOUT URINE OUTPUT THROUGH THE CATHETER AND OVERFLOW INCONTINENCE AROUND IT. IN THE EMERGENCY DEPARTMENT, THE CATHETER COULD BE FORWARD FLUSHED BUT NOT ASPIRATED. WHEN THEY ATTEMPTED TO CHANGE THE CATHETER AND DEFLATED THE BALLOON, URINE BEGAN FLOWING, BUT ASPIRATION WAS STILL NOT POSSIBLE. AFTER REMOVED THE CATHETER, THEY CONFIRMED THE BALLOON WAS INTACT, THOUGH IT WAS VERY DIFFICULT TO DEFLATE AND THE BALLOON PORT COLLAPSED, COMPLICATING DEFLATION. WITH SLOW, STEADY TRACTION ON THE SYRINGE, THEY WAS EVENTUALLY ABLE TO COMPLETELY DEFLATE IT AND REPLACE THE CATHETER. THE SECOND PATIENT, FROM (B)(6) 2026, PRESENTED TO THE CLINIC ON (B)(6) 2026 WITH THE SAME COMPLAINT THEIR CATHETER ALSO FLUSHED EASILY BUT COULD NOT ASPIRATE. REPLACEMENT WAS SIMILARLY DIFFICULT DUE TO RESISTANCE DURING BALLOON DEFLATION, THOUGH DEFLATION WAS ULTIMATELY ACHIEVABLE. AFTER REMOVAL, THE CATHETER FLUSHED WELL BUT STILL DID NOT ASPIRATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512842 ↗
• MalfunctionMar 4, 2026Inability to Irrigate; Failure to Infuse

  IT WAS REPORTED THAT BOTH OF THEIR ROBOTIC-ASSISTED LAPAROSCOPIC PROSTATECTOMY PATIENTS FROM (B)(6) 2026 AND (B)(6) 2026 HAD NOW PRESENTED WITH FOLEY CATHETER MALFUNCTIONS. THE PATIENT FROM (B)(6) 2026 CAME TO THE EMERGENCY DEPARTMENT ON (B)(6) 2026 REPORTED SEVERAL HOURS WITHOUT URINE OUTPUT THROUGH THE CATHETER AND OVERFLOW INCONTINENCE AROUND IT. IN THE EMERGENCY DEPARTMENT, THE CATHETER COULD BE FORWARD FLUSHED BUT NOT ASPIRATED. WHEN THEY ATTEMPTED TO CHANGE THE CATHETER AND DEFLATED THE BALLOON, URINE BEGAN FLOWING, BUT ASPIRATION WAS STILL NOT POSSIBLE. AFTER REMOVED THE CATHETER, THEY CONFIRMED THE BALLOON WAS INTACT, THOUGH IT WAS VERY DIFFICULT TO DEFLATE AND THE BALLOON PORT COLLAPSED, COMPLICATING DEFLATION. WITH SLOW, STEADY TRACTION ON THE SYRINGE, THEY WAS EVENTUALLY ABLE TO COMPLETELY DEFLATE IT AND REPLACE THE CATHETER. THE SECOND PATIENT, FROM (B)(6) 2026, PRESENTED TO THE CLINIC ON (B)(6) 2026 WITH THE SAME COMPLAINT. THEIR CATHETER ALSO FLUSHED EASILY BUT COULD NOT ASPIRATE. REPLACEMENT WAS SIMILARLY DIFFICULT DUE TO RESISTANCE DURING BALLOON DEFLATION, THOUGH DEFLATION WAS ULTIMATELY ACHIEVABLE. AFTER REMOVAL, THE CATHETER FLUSHED WELL BUT STILL DID NOT ASPIRAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512584 ↗
• InjuryMar 4, 2026Inaccurate Flow Rate; Difficult to Remove

  IT WAS REPORTED THAT BOTH OF THEIR ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMY PATIENTS FROM (B)(6) 2026 AND (B)(6) 2026 HAD NOW PRESENTED WITH FOLEY CATHETER MALFUNCTIONS. THE PATIENT FROM (B)(6) 2026 CAME TO THE EMERGENCY DEPARTMENT ON (B)(6) 2026 REPORTED SEVERAL HOURS WITHOUT URINE OUTPUT THROUGH THE CATHETER AND OVERFLOW INCONTINENCE AROUND IT. IN THE EMERGENCY DEPARTMENT, THE CATHETER COULD BE FORWARD FLUSHED BUT NOT ASPIRATED. WHEN THEY ATTEMPTED TO CHANGE THE CATHETER AND DEFLATED THE BALLOON, URINE BEGAN FLOWING, BUT ASPIRATION WAS STILL NOT POSSIBLE. AFTER REMOVED THE CATHETER, THEY CONFIRMED THE BALLOON WAS INTACT, THOUGH IT WAS VERY DIFFICULT TO DEFLATE AND THE BALLOON PORT COLLAPSED, COMPLICATING DEFLATION. WITH SLOW, STEADY TRACTION ON THE SYRINGE, THEY WAS EVENTUALLY ABLE TO COMPLETELY DEFLATE IT AND REPLACE THE CATHETER. THE SECOND PATIENT, FROM (B)(6) 2026, PRESENTED TO THE CLINIC ON (B)(6) 2026 WITH THE SAME COMPLAINT THEIR CATHETER ALSO FLUSHED EASILY BUT COULD NOT ASPIRATE. REPLACEMENT WAS SIMILARLY DIFFICULT DUE TO RESISTANCE DURING BALLOON DEFLATION, THOUGH DEFLATION WAS ULTIMATELY ACHIEVABLE. AFTER REMOVAL, THE CATHETER FLUSHED WELL BUT STILL DID NOT ASPIRATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507250 ↗
• 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 ↗
• MalfunctionFeb 20, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE CAREGIVER SAID THAT A COUPLE OF THEM DEFLATED BUT THEY WERE ABLE TO INFLATE AGAIN SO WAS NOT SO BAD CG SAID. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400323 ↗

Other C. R. Bard, Inc. products

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• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
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• Bardex All-Silicone Foley Catheter12 models · 1,170 reports