Bard® Silastic® Foley Catheter 33620Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00801741020087), received between Apr 20, 2017 and Mar 12, 2026 — classified as 11 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (10 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 50 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionFeb 5, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT SAID TWO CATHETERS ARE NOT ALLOWING URINE TO FLOW/NOT DRAINING. PATIENT HAS TO DEFLATE THE BALLOON TO RELEASE THE URINE. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268758 ↗
• MalfunctionFeb 5, 2026Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT SAID TWO CATHETERS ARE NOT ALLOWING URINE TO FLOW/NOT DRAINING. PATIENT HAS TO DEFLATE THE BALLOON TO RELEASE THE URINE. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268756 ↗
• MalfunctionDec 10, 2025Collapse; Collapse

  IT WAS REPORTED THAT MIRAMICHI UNIT WAS HAVE ISSUES WITH THE BD SILASTIC CATHETERS, HAVING AN INCREASED NUMBER OF BLOCKED CATHETERS. CUSTOMER COULD FLUSH ALL THEY WANT BUT NOTHING COMES BACK OUT, AND WATER WAS VERY HARD TO REMOVE FROM THE BULB AS THE CATHETERS COLLAPSE ON ITS OWN PIPE. DEMI EVEN HAD TO SEND A PATIENT TO ER AS THE PATIENT COULDN'T DEFLATE THE BULB, AND ANOTHER PATIENT ALMOST HAD THE SAME THING HAPPENED TO HER, BUT THEN FINALLY FOUND A WAY TO REMOVE IT AFTER PLAYING WITH IT FOR MORE THAN 20 MINS. SAME THING HAPPENED TO ME THE LAST NIGHT I WAS ON CALL IT TOOK ME FOREVER TO REMOVE THE WATER FROM THE BULB AS THE PIPE WOULD JUST COLLAPSE ON ITSELF WHILE TRYING TO REMOVE THE WATER FROM THE BULB. SOME PATIENT ENDS UP WITH VERY FULL BLADDERS BECAUSE OF THIS ISSUE AND THE ONLY WAY URINE COMES OUT IN THE BAG OF FROM THE PENIS (FOR THE ONES THAT HAS SUPRAPUBIC CATHETERS) WAS IF THEIR BLADDERS ARE SUPER FULL. THIS HAS BEEN HAPPENING NOT JUST IN NEGUAC BUT EVERYWHERE. I HAD NEVER TESTED BALLOON BEFORE INSERTING A CATHETER EVER. THERE WAS NOT A MILLION WAYS TO PUT A CATHETER IN, AND WE HAVE BEEN DOING SO FOR YEARS, I DON'T THINK WE ALL OF A SUDDEN LOST OUR ABILITY TO PUT A CATHET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769559 ↗
• InjuryDec 10, 2025Collapse; Collapse

  IT WAS REPORTED THAT MIRAMICHI UNIT WAS HAVE ISSUES WITH THE BD SILASTIC CATHETERS, HAVING AN INCREASED NUMBER OF BLOCKED CATHETERS. CUSTOMER COULD FLUSH ALL THEY WANT BUT NOTHING COMES BACK OUT, AND WATER WAS VERY HARD TO REMOVE FROM THE BULB AS THE CATHETERS COLLAPSE ON ITS OWN PIPE. DEMI EVEN HAD TO SEND A PATIENT TO ER AS THE PATIENT COULDN'T DEFLATE THE BULB, AND ANOTHER PATIENT ALMOST HAD THE SAME THING HAPPENED TO HER, BUT THEN FINALLY FOUND A WAY TO REMOVE IT AFTER PLAYING WITH IT FOR MORE THAN 20 MINS. SAME THING HAPPENED TO ME THE LAST NIGHT I WAS ON CALL IT TOOK ME FOREVER TO REMOVE THE WATER FROM THE BULB AS THE PIPE WOULD JUST COLLAPSE ON ITSELF WHILE TRYING TO REMOVE THE WATER FROM THE BULB. SOME PATIENT ENDS UP WITH VERY FULL BLADDERS BECAUSE OF THIS ISSUE AND THE ONLY WAY URINE COMES OUT IN THE BAG OF FROM THE PENIS (FOR THE ONES THAT HAS SUPRAPUBIC CATHETERS) WAS IF THEIR BLADDERS ARE SUPER FULL. THIS HAS BEEN HAPPENING NOT JUST IN NEGUAC BUT EVERYWHERE. I HAD NEVER TESTED BALLOON BEFORE INSERTING A CATHETER EVER. THERE WAS NOT A MILLION WAYS TO PUT A CATHETER IN, AND WE HAVE BEEN DOING SO FOR YEARS, I DON'T THINK WE ALL OF A SUDDEN LOST OUR ABILITY TO PUT A CATHET

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

  MAUDE report 23768971 ↗
• MalfunctionDec 10, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT MIRAMICHI UNIT WAS HAVE ISSUES WITH THE BD SILASTIC CATHETERS, HAVING AN INCREASED NUMBER OF BLOCKED CATHETERS. CUSTOMER COULD FLUSH ALL THEY WANT BUT NOTHING COMES BACK OUT, AND WATER WAS VERY HARD TO REMOVE FROM THE BULB AS THE CATHETERS COLLAPSE ON ITS OWN PIPE. DEMI EVEN HAD TO SEND A PATIENT TO ER AS THE PATIENT COULDN'T DEFLATE THE BULB, AND ANOTHER PATIENT ALMOST HAD THE SAME THING HAPPENED TO HER, BUT THEN FINALLY FOUND A WAY TO REMOVE IT AFTER PLAYING WITH IT FOR MORE THAN 20 MINS. SAME THING HAPPENED TO ME THE LAST NIGHT I WAS ON CALL IT TOOK ME FOREVER TO REMOVE THE WATER FROM THE BULB AS THE PIPE WOULD JUST COLLAPSE ON ITSELF WHILE TRYING TO REMOVE THE WATER FROM THE BULB. SOME PATIENT ENDS UP WITH VERY FULL BLADDERS BECAUSE OF THIS ISSUE AND THE ONLY WAY URINE COMES OUT IN THE BAG OF FROM THE PENIS (FOR THE ONES THAT HAS SUPRAPUBIC CATHETERS) WAS IF THEIR BLADDERS ARE SUPER FULL. THIS HAS BEEN HAPPENING NOT JUST IN NEGUAC BUT EVERYWHERE. I HAD NEVER TESTED BALLOON BEFORE INSERTING A CATHETER EVER. THERE WAS NOT A MILLION WAYS TO PUT A CATHETER IN, AND WE HAVE BEEN DOING SO FOR YEARS, I DON'T THINK WE ALL OF A SUDDEN LOST OUR ABILITY TO PUT A CATHET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768970 ↗
• MalfunctionOct 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE CUSTOMER HAS REPORTED A DEFECTIVE ITEM. CUSTOMER HAD USED AT LEAST ONE OTHER OUT OF THIS SAME LOT THAT DID NOT HAVE AN ISSUE. THE INFORMATION THAT WAS PASSED WAS ¿PREPARING FOR CATHETER INSERTION AND CONFIRMING THAT THE BALLOON WILL INFLATE AND DEFLATE WITH 10 ML NS, THE BALLOON INFLATES HOWEVER DOES NOT DEFLATE. IT APPEARS POSSIBLE CONCERN WITH THE VALVE FUNCTION¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23265993 ↗
• MalfunctionOct 9, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT UNABLE TO DEFLATE THE BALLOON ONCE THE CATHETER WAS NEEDING TO BE REPLACED. NO FLUID WAS ABLE TO BE PULLED INTO THE SYRINGE TO DEFLATE THE BALLOON. SERIAL/LOT NUMBER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23257439 ↗
• MalfunctionOct 9, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT PER CUSTOMER PO# (B)(4), LINE 20, PRODUCT 336-20, LOT NGKS5060 IS THE ITEM THAT HAD THE ISSUE. THEY HAVE USED AT LEAST ONE OTHER OUT OF THIS SAME LOT THAT DID NOT HAVE AN ISSUE. THE INFORMATION THAT WAS PASSED IS WHILE PREPARING FOR CATHETER INSERTION AND CONFIRMING THAT THE BALLOON WILL INFLATE AND DEFLATE WITH 10 ML NS, THE BALLOON INFLATES HOWEVER DOES NOT DEFLATE. IT APPEARS POSSIBLE CONCERN WITH THE VALVE FUNCTION. PER FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2025, RN ATTEMPTED TO INFLATE BALLOON PRIOR TO INSERTION MALFUNCTION FOUND PRIOR TO INSERTION. DURING PREP OF FOLEY INSERTION PROCEDURE, RN WAS VERIFYING BALLOON INFLATION AND DEFLATION PRIOR TO INSERTION AT BEDSIDE, THE BALLOON INFLATED HOWEVER WOULD NOT DEFLATE. FOLEY NOT USED AND ANOTHER FOLEY CATHETER OBTAINED, VERIFIED INFLATION AND DEFLATION. PROCEDURE COMPLETED WITH 2ND CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23257414 ↗
• MalfunctionOct 7, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT UNABLE TO DEFLATE THE BALLOON ONCE THE CATHETER WAS NEEDING TO BE REPLACED. NO FLUID WAS ABLE TO BE PULLED INTO THE SYRINGE TO DEFLATE THE BALLOON. SERIAL/LOT NUMBER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23234540 ↗
• MalfunctionOct 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE USER EXPLAINED THE FOLEY BALLOONS FAILED. THEY HAVE BEEN USING THESE FOR A WHILE AND KNOW HOW TO USE THEM AND HAVE NOT HAD THESE ISSUES BEFORE. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 08DEC2025, IT WAS REPORTED THAT " "HER CUSTOMER WAS ADVISED TO RETURN THE DEFECTIVE ITEM TO YOU. LOOKS LIKE THE CUSTOMER MIGHT HAVE CONTACTED YOU DIRECTLY AND HAS THE DEFECTIVE ITEM RETURNED"."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23222986 ↗
• MalfunctionSep 19, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CUSTOMER CONCERN REGARDING THE SILASTIC¿ 2-WAY, SPECIALTY, SHORT ROUND TIP CATHETER (SKU#: 33620), SPECIFICALLY THOSE FROM LOT#: NGKQ1139. THE CUSTOMER ORDERED THIS PRODUCT, WHO USED THE CATHETER THROUGH A STOMA. THEY REPORTED THAT THEY USED THREE CATHETERS FROM THIS LOT, AND NONE FUNCTIONED PROPERLY. THE ISSUE INVOLVED URINE NOT DRAINING INTO THE NIGHT BAG, RESULTING IN URINE BACKING UP IN THE BLADDER OVER A PERIOD OF 2¿3 DAYS. IN ONE INSTANCE, THEY HAD TO VISIT THE EMERGENCY ROOM DUE TO PAINFUL RETENTION. UPON DEFLATION OF THE CATHETER BALLOON BY A NURSE, APPROXIMATELY 2000CC OF URINE RAPIDLY DRAINED INTO THE NIGHT BAG. THE BALLOON WAS REINFLATED WITH 5CC, BUT THE SAME ISSUE RECURRED TWO DAYS LATER. THE CUSTOMER SUSPECTS A MALFUNCTION WITH THE CATHETER BALLOON, AS URINE ONLY DRAINS PROPERLY ONCE THE BALLOON WAS DEFLATED. ADVISED ON NEXT STEPS FOR INVESTIGATING THIS ISSUE. THE CUSTOMER WAS CONCERNED ABOUT THE SAFETY AND RELIABILITY OF THIS PRODUCT BATCH. THE CUSTOMER REPORTED THAT THEY ORDERED A NEW SHIPMENT OF SILASTIC¿, 2-WAY, SPECIALTY, SHORT ROUND TIP CATHETERS (SKU#: 33620). SINCE USING THE PRODUCT FROM LOT#: NGKQ1139, THEY'VE EXPERIENCED ISSUES WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098802 ↗
• InjurySep 19, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CUSTOMER CONCERN REGARDING THE SILASTIC¿ 2-WAY, SPECIALTY, SHORT ROUND TIP CATHETER (SKU# 33620), SPECIFICALLY THOSE FROM LOT# NGKQ1139. THE CUSTOMER ORDERED THIS PRODUCT, WHO USED THE CATHETER THROUGH A STOMA. THEY REPORTED THAT THEY USED THREE CATHETERS FROM THIS LOT, AND NONE FUNCTIONED PROPERLY. THE ISSUE INVOLVED URINE NOT DRAINING INTO THE NIGHT BAG, RESULTING IN URINE BACKING UP IN THE BLADDER OVER A PERIOD OF 2¿3 DAYS. IN ONE INSTANCE, THEY HAD TO VISIT THE EMERGENCY ROOM DUE TO PAINFUL RETENTION. UPON DEFLATION OF THE CATHETER BALLOON BY A NURSE, APPROXIMATELY 2000CC OF URINE RAPIDLY DRAINED INTO THE NIGHT BAG. THE BALLOON WAS REINFLATED WITH 5CC, BUT THE SAME ISSUE RECURRED TWO DAYS LATER. THE CUSTOMER SUSPECTS A MALFUNCTION WITH THE CATHETER BALLOON, AS URINE ONLY DRAINS PROPERLY ONCE THE BALLOON WAS DEFLATED. ADVISED ON NEXT STEPS FOR INVESTIGATING THIS ISSUE. THE CUSTOMER WAS CONCERNED ABOUT THE SAFETY AND RELIABILITY OF THIS PRODUCT BATCH. THE CUSTOMER REPORTED THAT THEY ORDERED A NEW SHIPMENT OF SILASTIC¿, 2-WAY, SPECIALTY, SHORT ROUND TIP CATHETERS (SKU# 33620). SINCE USING THE PRODUCT FROM LOT# NGKQ1139, THEY¿VE EXPERIENCED ISSUES WITH URIN

  Patient problems: Pain

  MAUDE report 23098447 ↗
• MalfunctionSep 16, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE CUSTOMER INFORMED FOLEY CATHETER WAS CLOGGED AND MALFUNCTIONING OF THE RELEASE OF THE BALLOON. CUSTOMER ALSO MENTIONED IT WAS DIFFICULT TO TELL WHEN THE BALLOON WAS FULL DEFLATED. INFORMED IT HAPPENED 4 CASES SO FAR. TWICE ON THE SAME PATIENT. CUSTOMER IS LOOKING TO RETURN ALL 6 CASES REMAINING. CUSTOMER CONFIRMED ALL 6 CASES HAVE THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065414 ↗
• MalfunctionSep 16, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT CUSTOMER INFORMED FOLEY CATHETER WAS CLOGGED AND MALFUNCTIONING OF THE RELEASE OF THE BALLOON. CUSTOMER ALSO MENTIONED IT WAS DIFFICULT TO TELL WHEN THE BALLOON WAS FULL DEFLATED. INFORMED IT HAPPENED 4 CASES SO FAR. TWICE ON THE SAME PATIENT. CUSTOMER IS LOOKING TO RETURN ALL 6 CASES REMAINING. CUSTOMER CONFIRMED ALL 6 CASES HAVE THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065412 ↗
• MalfunctionSep 16, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE CUSTOMER INFORMED FOLEY CATHETER WAS CLOGGED AND MALFUNCTIONING OF THE RELEASE OF THE BALLOON. CUSTOMER ALSO MENTIONED IT WAS DIFFICULT TO TELL WHEN THE BALLOON WAS FULL DEFLATED. INFORMED IT HAPPENED 4 CASES SO FAR. TWICE ON THE SAME PATIENT. CUSTOMER IS LOOKING TO RETURN ALL 6 CASES REMAINING. CUSTOMER CONFIRMED ALL 6 CASES HAVE THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065411 ↗
• MalfunctionSep 16, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT 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. IT WAS REPORTED THAT THE GIVEN LOT# WAS NGJX5831.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062838 ↗
• InjurySep 10, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED BY A CUSTOMER THAT AN ISSUE WITH A CATHETER THAT HAS PERSISTED FOR APPROXIMATELY ONE MONTH. THE CATHETER HAS CONSISTENTLY FAILED TO ALLOW URINE TO DRAIN PROPERLY. AS A RESULT OF THIS MALFUNCTION, SIGNIFICANT EXPENSES HAVE BEEN INCURRED DUE TO THE REPEATED PURCHASE OF INCONTINENCE PRODUCTS. REF 33620 LOT NGJX5830. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 27AUG2025, IT WAS REPORTED THAT PATIENT HAS A SUPER PUBIC CATHETER AND HAS HAD ONE MORE FOR MORE THAN 4 YEARS. ABOUT ONE MONTH AGO, AFTER A CATHETER CHANGE, URINE WAS NOT FLOWING INTO THE CATHETER TUBING BUT RATHER WAS COMING OUT OF THE SUPRAPUBIC SITE. THEY CALLED THEIR HOME CARE AGENCY, AND THEY CHANGED THE CATHETER AGAIN. (INTERESTINGLY, THEY HAD ONE BOX AND 2 LOOSE BARD CATHETERS ALL WITH THE SAME LOT#). PATIENT CONTINUED LEAKING URINE, SO MUCH SO THAT THEY WERE PADDING PATIENT'S DIAPERS (PATIENT WAS A BOWEL INCONTINENT AS WELL) WITH PATIENT'S NIGHT GUARDS, PATIENT WAS SITTING AND LAYING ON CHUX DISPOSABLE PADS, NEEDING CHANGED SEVERAL TIMES A DAY. LITTLE TO NO URINE WAS PASSING IN THE CATHETER LINE. PATIENT WAS DIAGNOSED WITH A BACTERIAL UTI, AND ANOTHER (3RD) CATHETER CHANGE WAS MADE. THEY SUGGESTED IT

  Patient problems: Cramp(s) /Muscle Spasm(s); Urinary Tract Infection

  MAUDE report 23020348 ↗
• InjurySep 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A CUSTOMER THAT AN ISSUE WITH A CATHETER THAT HAS PERSISTED FOR APPROXIMATELY ONE MONTH. THE CATHETER HAS CONSISTENTLY FAILED TO ALLOW URINE TO DRAIN PROPERLY. AS A RESULT OF THIS MALFUNCTION, SIGNIFICANT EXPENSES HAVE BEEN INCURRED DUE TO THE REPEATED PURCHASE OF INCONTINENCE PRODUCTS. REF 33620 LOT NGJX5830. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2025, IT WAS REPORTED THAT PATIENT HAS A SUPER PUBIC CATHETER AND HAS HAD ONE MORE FOR MORE THAN 4 YEARS. ABOUT ONE MONTH AGO, AFTER A CATHETER CHANGE, URINE WAS NOT FLOWING INTO THE CATHETER TUBING BUT RATHER WAS COMING OUT OF THE SUPRAPUBIC SITE. THEY CALLED THEIR HOME CARE AGENCY, AND THEY CHANGED THE CATHETER AGAIN. (INTERESTINGLY, THEY HAD ONE BOX AND 2 LOOSE BARD CATHETERS ALL WITH THE SAME LOT#). PATIENT CONTINUED LEAKING URINE, SO MUCH SO THAT THEY WERE PADDING PATIENT'S DIAPERS (PATIENT WAS A BOWEL INCONTINENT AS WELL) WITH PATIENT'S NIGHT GUARDS, PATIENT WAS SITTING AND LAYING ON CHUX DISPOSABLE PADS, NEEDING CHANGED SEVERAL TIMES A DAY. LITTLE TO NO URINE WAS PASSING IN THE CATHETER LINE. PATIENT WAS DIAGNOSED WITH A BACTERIAL UTI, AND ANOTHER (3RD) CATHETER CHANGE WAS MADE. THEY SUGGESTED I

  Patient problems: Bacterial Infection; Fecal Incontinence; Urinary Tract Infection

  MAUDE report 23020347 ↗