Bard® Silastic® Foley Catheter 33616Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741020063), received between Oct 23, 2017 and Jan 26, 2026 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 23, 2026Open, Classified

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

   Z-2226-2026 · Root cause: Material/Component Contamination · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Inaccurate Flow Rate

  IT WAS REPORTED BY A CARE PROVIDER THAT THE 33616 HAS A DEFECTIVE STRUCTURAL INTEGRITY. NOT ALLOWING URINE DRAINAGE WHEN INSERTED. PREVIOUS FOLEY CATHETERS DID NOT CAUSE ANY ISSUE WITH DRAINING WHILE INSERTED. FOLEY CATHETER HAS BEEN REPOSITIONED AND ATTEMPTED TO BE ADJUSTED. NO RESOLVE. FOLEY DEFECTS ARE CAUSING PATIENT TO USE SUPPLIES SOONER. SENDING EXCHANGED ORDER. APOLOGIZED FOR DISCOMFORT EXPERIENCE. 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 24185156 ↗
• MalfunctionDec 12, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY THE CUSTOMER STATED THE CATHETER 33616 (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 33618 (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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790924 ↗
• MalfunctionDec 10, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT AFTER INSERTION OF NEW 16FR SILASTIC FOLEY CATHETER 10CC SYRINGE FILLED WITH STERILE WATER ATTACHED TO RETENTION BALLOON PORT. AS BALLOON HAS BEEN ATTACHED AND INFLATED THE ENTIRE BALLOON PORT CAME OFF CATHETER TUBING. THAT MALFUNCTION OCCURRED WITH 2 DIFFERENT CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771544 ↗
• MalfunctionDec 10, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE INDWELLING FOLEY CATHETER MALFUNCTION; AFTER INSERTION OF NEW 16FR SILASTIC FOLEY CATHETER. 10CC SYRINGE FILLED WITH STERILE WATER ATTACH TO RETENTION BALLOON PORT. AS BALLOON WAS BEING ATTACHED AND INFLATED THE ENTIRE BALLOON PORT CAME OFF CATHETER TUBING. THIS MALFUNCTION OCCURRED WITH 2 DIFFERENT CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771173 ↗
• MalfunctionNov 24, 2025Inflation Problem; Inflation Problem

  PATIENT ADVISED THE BALLOON IS NOT INFLATING AND THE RED PRODUCT MARKER IS COMING OFF 7 CATHETERS. PATIENT DID NOT PURCHASE THROUGH LMS. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 12NOV2025, YES, THEY HAVE RETAINED ONE OF THE CATHETERS THAT EXHIBITED THE ISSUE, ALONG WITH ITS ORIGINAL OUTER PACKAGING. THEY WOULD BE GLAD TO SEND IT FOR INVESTIGATION. THE LOT AND SERIAL NUMBERS WERE PRESENT ON THE OUTER PACKAGING WHICH THEY HAVE SAVED. THEY COULD PROVIDE THESE DETAILS, OR THEY WOULD BE AVAILABLE ON THE PHYSICAL SAMPLE AND PACKAGING IF THEY PREFER TO HAVE THEM SHIPPED TO THEM. THERE HAS BEEN A SIGNIFICANT AND DISTRESSING IMPACT ON THE PATIENT. THIS WAS, IN FACT, THE SECOND TIME THEY HAVE ENCOUNTERED SEVERE ISSUES WITH THESE CATHETERS. CUSTOMER WAS EXPERIENCING VISIBLE SWELLING AND IRRITATION IN THE AREA. EACH TIME THEY HAD TO CHANGE A FAULTY CATHETER, THEY SCREAM DUE TO THE PAIN. ON ONE PARTICULAR DAY, THEY HAD TO CHANGE THE CATHETER THREE TIMES BECAUSE THE BALLOON WOULD NOT INFLATE ONCE IT WAS PROPERLY INSERTED. OTHER CATHETERS FROM THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632138 ↗
• MalfunctionNov 7, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT URINARY FOLEY CATHETER INSERTED ACCORDING TO PROPER TECHNIQUE WITH 10 ML IN THE BALLOON NO DRAINAGE, IRRIGATION POSSIBLE. CATHETER REMOVED. SECOND CATHETER INSERTED NO DRAINAGE IRRIGATION POSSIBLE; WHEN STAFF ATTEMPT TO REMOVE THE WATER FROM THE BALLOON, CATHETER COLLAPSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498374 ↗
• MalfunctionNov 7, 2025Collapse; Collapse

  IT WAS REPORTED THAT URINARY FOLEY CATHETER INSERTED ACCORDING TO PROPER TECHNIQUE WITH 10 ML IN THE BALLOON NO DRAINAGE, IRRIGATION POSSIBLE. CATHETER REMOVED. SECOND CATHETER INSERTED NO DRAINAGE IRRIGATION POSSIBLE; WHEN STAFF ATTEMPT TO REMOVE THE WATER FROM THE BALLOON, CATHETER COLLAPSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498373 ↗
• MalfunctionNov 3, 2025Complete Blockage; Complete Blockage

  PATIENT SAID EXPERIENCED LEAKS AND THE FOLEY CLOGGED AND STOPPED DRAINING SOON AFTER PUTTING IT ON. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 30DEC2025, IT WAS REPORTED THAT THE CATHETER SEEMED TO BE DEFECTIVE BECAUSE IT WAS CLOGGED AND WOULD NOT ALLOW URINE TO PASS. A REPLACEMENT WAS SENT TO THE CUSTOMER, AND THE DEFECTIVE CATHETER WAS DISCARDED. THEREFORE, NO SAMPLE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453179 ↗
• MalfunctionOct 6, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT 1 PIECE OF FOLEY CATHETER WITH EMPTY PACKAGING CODE 33616 LOT NGJW0884 WAS DETECTED. WHEN TRACKING, THERE WAS AN ENTRY OF 29MAY2025 OF THE MENTIONED LOT, ENTRY VOUCHER 5001015684, ORDER (B)(4). THEREFORE, FOLIO RIP-144-2025 WAS GENERATED AND 1 PIECE WAS BLOCKED IN THE SET. ADDITIONAL INFORMATION RECEIVED ON 25 SEP 2025. THE DEFECT WAS DETECTED ON (B)(6) 2025. THE SAMPLE IS AVAILABLE FOR RETURN AND ANALYSIS. THE PACKAGING HAS NO LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23222167 ↗
• MalfunctionMar 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD POPPED OUT OF THE PATIENT'S BODY AND WAS INSERTED BY A PHYSICIAN. THEY SAID THAT THE BALLOON POPPED AND WAS NEEDING A REPLACEMENT FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632623 ↗
• MalfunctionDec 27, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE FOLEY CATHETER HUB DISCONNECTED AND REMAINED ATTACHED TO THE SYRINGE WHEN BALLOON INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026679 ↗
• MalfunctionNov 27, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT CUSTOMER RECEIVED A BOX AND ONE MISSING FOLEY CATHETER JUST AN EMPTY PACKAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796251 ↗
• MalfunctionSep 4, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PROBE DID NOT HAVE THE ORANGE FILLING VALVE, WHERE THE SYRINGE WAS CONNECTED TO INSUFFLATE THE FOLEY CATHETER BALLOON, THE PROBE WAS NOT USED IN PATIENT, IT WAS NOT OPENED, THE TRANSPARENT PACKAGING ALLOWED TO SEE THAT THE PROBE WAS MISSING AN ACCESSORY. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 23AUG2024, CUSTOMER CONFIRMED THAT THE INFLATION VALVE WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137523 ↗
• MalfunctionJul 2, 2024Device Damaged Prior to Receipt by User; Component Missing; Device Damaged Prior to Receipt by User; Component Missing

  IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED THE BOX OF 33616 CATHETERS, THERE WERE ONLY 9 CATHETERS INSIDE AND 1 WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655350 ↗
• MalfunctionFeb 1, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A DEFECTIVE FOLEY CATHETER WHICH WAS CLOGGED AND NEEDED TO FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621503 ↗
• MalfunctionNov 7, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER HAD RECEIVED A DEFECTIVE ITEM. THE ISSUE WAS THAT THE CATHETER WAS GETTING CLOGGED AND THEY NEEDED TO FLUSH. AS PER FOLLOW-UP INFORMATION RECEIVED FROM CUSTOMER ON 03NOV2023, STATED THAT THEY HAD AN ISSUE WITH THE LEG BAG AND ISSUE WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083856 ↗
• MalfunctionJul 25, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS NO ORANGE PART IN THE BEGINNING OF THE FOLEY CATHETER. THAT IS, THE PROBE WAS MISSING A PIECE. THE PROBE WAS NOT USED IN PATIENT, THE PROBE WAS INSIDE THE ORIGINAL CLOSED PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389396 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THESE SILASTIC FOLEY CATHETERS CAUSED INFECTIONS TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16062171 ↗
• MalfunctionNov 16, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT BALLOONS OF ALL THE 3 FOLEY CATHETERS EXPLODED WITHIN AN HOUR. PER FOLLOW UP VIA PHONE ON (B)(6) 2022, CUSTOMER STATED THAT THEY WENT THROUGH 3 FOLEY CATHETERS WITHIN AN HOUR DUE TO EACH ONE BURSTING AFTER A FEW MINUTES OF USE. STATED THAT THEY INSERTED THE CATHETER AND FILLED WITH 10CC THEN WENT TO SIT TO WATCH TELEVISION AND WITHIN A FEW MINUTES, THEY NOTICED THE BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15810570 ↗
• MalfunctionMay 19, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE NURSE COULD NOT GET THE FOLEY CATHETERS IN AND HAD TO USE A FEW. STATED THAT THE CATHETERS HAD KINKS IN THEM WHICH WAS CAUSED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14433968 ↗
• MalfunctionApr 6, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE NURSE WENT TO CHANGE A PATIENT¿S CATHETER AND THERE WERE NO ISSUES. A FEW HOURS LATER, THE PATIENT FELT A SPRING AND SNAP IN THEIR BLADDER, BUT THE CATHETER SEEMED TO BE DRAINING STILL. THEN SHORTLY LATER THE PATIENT REPORTED WETNESS AND CATHETER BEGAN LEAKING. NURSE RETURNED TO THE PATIENT AND DISCOVERED THAT THE CATHETER HAD BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021417 ↗
• MalfunctionMay 13, 2021Component Misassembled; Missing Information; Component Misassembled; Missing Information

  IT WAS REPORTED THAT A PIECE OF THE FOLEY CATHETER ARRIVED INCOMPLETE BECAUSE IT LACKED THE IDENTIFICATION COLOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820057 ↗
• MalfunctionMay 28, 2020Failure to Infuse; Inflation Problem; Failure to Infuse

  IT WAS REPORTED THAT THE CATHETER BALLOON WOULD NOT INFLATE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10095909 ↗
• MalfunctionMar 12, 2020Material Rupture; Component Missing

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER ALLEGEDLY RUPTURED DURING PATIENT USE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 27 FEB 2020 FROM IBC REPRESENTATIVE, A PIECE OF THE BALLOON WAS MISSING. THE PIECE COULD NOT BE FOUND. THERE WAS NO REPORTED PATIENT INJURY. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 2 MARCH 2020 FROM IBC REPRESENTATIVE, THERE WAS NO PROCEDURE PERFORMED TO LOCATE THE MISSING PIECE. THERE IS NO INJURY TO THE PATIENT.

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

  MAUDE report 9824571 ↗
• MalfunctionJan 3, 2020Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SILASTIC FOLEY CATHETER WAS DIFFICULT TO REMOVE AND WAS GETTING STUCK IN THE URINARY TRACT. THE COMPLAINANT REPORTED THAT THE CATHETER WAS CUT IN ORDER FOR THE BALLOON TO BE PROPERLY DEFLATED, AND THE CATHETER WAS REMOVED FROM THE PATIENT. THE PATIENT REPORTEDLY EXPERIENCED PAIN. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9544569 ↗