Bardex® I.C. Foley Catheter 0166SI18Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741016851), received between Apr 8, 2019 and Jun 23, 2025 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON THE FIRST DAY OF PLACEMENT AFTER TOTAL CYSTECTOMY THE FOLEY CATHETER BALLOON BURST A WHILE LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308646 ↗
• MalfunctionJun 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER WAS RUPTURED AFTER 1ST DAY OF PLACEMENT OF A CATHETER IN THE PELVIS AFTER TOTAL CYSTECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236024 ↗
• MalfunctionDec 13, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT FOLEY CATHETER GOT CLOGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925863 ↗
• MalfunctionMay 6, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS PLACED IN DETENTION ON (B)(6) 2024, AND THE CATHETER WAS REMOVED NATURALLY ON (B)(6) 2024 WHEN THE BALLOON RAN OUT OF WATER. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 17APR2024, STATED THAT NO ABNORMALITIES WERE IDENTIFIED THROUGHOUT THE CATHETER. BAGS FROM OTHER MANUFACTURERS WERE DISCARDED. NO LEAFLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247734 ↗
• MalfunctionApr 21, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON RUPTURED ABOUT 45 MINUTES AFTER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166471 ↗
• InjuryApr 19, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE CUSTOMER HAS HAD 3 OF THE FOLEY CATHETERS BALLOONS RUPTURED WHICH THEY WERE USING FOR INDUCTION. STATED THAT THE DOCTOR INSERTED THE FOLEY CATHETER THROUGH THE CERVIX, AND THEY INFLATED THE BALLOON WITH APPROXIMATELY 60ML OF NORMAL SALINE, WHICH DID EXCEED THE RECOMMENDED AMOUNT OF 30ML, BUT THEY HAVE USED THEM FOR YEARS THIS WAY WITH HARDLY ANY PROBLEMS. CUSTOMER ALSO STATED THAT THE PATIENT LAST WEEK THAT HAD THE FOLEY BREAK WENT FOR A C-SECTION AND THE DOCTOR FOUND A PART OF THE BALLOON INSIDE THE UTERUS. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. THE AFFECTED LOTS WERE NGFP3605, NGFT5738.

  Patient problems: Foreign Body In Patient

  MAUDE report 14140966 ↗
• MalfunctionApr 19, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE CUSTOMER HAS HAD 3 OF THE FOLEY CATHETERS BALLOONS RUPTURED WHICH THEY WERE USING FOR INDUCTION. STATED THAT THE DOCTOR INSERTED THE FOLEY CATHETER THROUGH THE CERVIX, AND THEY INFLATED THE BALLOON WITH APPROXIMATELY 60ML OF NORMAL SALINE, WHICH DID EXCEED THE RECOMMENDED AMOUNT OF 30ML, BUT THEY HAVE USED THEM FOR YEARS THIS WAY WITH HARDLY ANY PROBLEMS. CUSTOMER ALSO STATED THAT THE PATIENT LAST WEEK THAT HAD THE FOLEY BREAK WENT FOR A C-SECTION AND THE DOCTOR FOUND A PART OF THE BALLOON INSIDE THE UTERUS. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140962 ↗
• MalfunctionApr 14, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE CUSTOMER HAS HAD 3 OF THE FOLEY CATHETERS BALLOONS RUPTURED WHICH THEY WERE USING FOR INDUCTION. STATED THAT THE DOCTOR INSERTED THE FOLEY CATHETER THROUGH THE CERVIX, AND THEY INFLATED THE BALLOON WITH APPROXIMATELY 60ML OF NORMAL SALINE, WHICH DID EXCEED THE RECOMMENDED AMOUNT OF 30ML, BUT THEY HAVE USED THEM FOR YEARS THIS WAY WITH HARDLY ANY PROBLEMS. CUSTOMER ALSO STATED THAT THE PATIENT LAST WEEK THAT HAD THE FOLEY BREAK WENT FOR A C-SECTION AND THE DOCTOR FOUND A PART OF THE BALLOON INSIDE THE UTERUS. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112921 ↗
• InjuryApr 14, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE CUSTOMER HAS HAD 3 OF THE FOLEY CATHETERS BALLOONS RUPTURED WHICH THEY WERE USING FOR INDUCTION. STATED THAT THE DOCTOR INSERTED THE FOLEY CATHETER THROUGH THE CERVIX, AND THEY INFLATED THE BALLOON WITH APPROXIMATELY 60ML OF NORMAL SALINE, WHICH DID EXCEED THE RECOMMENDED AMOUNT OF 30ML, BUT THEY HAVE USED THEM FOR YEARS THIS WAY WITH HARDLY ANY PROBLEMS. CUSTOMER ALSO STATED THAT THE PATIENT LAST WEEK THAT HAD THE FOLEY BREAK WENT FOR A C-SECTION AND THE DOCTOR FOUND A PART OF THE BALLOON INSIDE THE UTERUS. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14112920 ↗
• MalfunctionDec 23, 2019Deflation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER DEFLATED DURING USE AND CAUSED THE CATHETER TO FALL OUT OF THE PATIENT.

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

  MAUDE report 9512705 ↗
• MalfunctionDec 23, 2019Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETER GOT CLOGGED PREVENTING IT FROM DRAINING PROPERLY AT TIMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9512423 ↗
• MalfunctionApr 9, 2019Incorrect Measurement; Material Deformation; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER APPEARED TO BE SHORTER THAN NORMAL.

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

  MAUDE report 8497732 ↗
• MalfunctionApr 8, 2019Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS ABOUT 3 INCHES SHORTER THAN USUAL. THE CUSTOMER REPORTED THAT THE CATHETER DID NOT REACH THE SAME PLACE THE PREVIOUS ONES DID WHEN IT WAS INSERTED.

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

  MAUDE report 8492810 ↗