Bardex® All-Silicone Foley Catheter 165814Recalls & reported problems

Summary

The FDA's MAUDE database contains 275 adverse event reports that list this exact device (DI 00801741029745), received between Apr 6, 2017 and Aug 25, 2026 — classified as 24 injuries, 251 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (53 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 25 most recent of 275 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50441867 ↗
• MalfunctionAug 4, 2026Difficult to Remove

  Patient problems: Pain

  MAUDE report 50130660 ↗
• MalfunctionJul 12, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PLACEMENT IN THE SURGERY CENTER THE FOLEY CATHETER HAD A CRACK, CAUSING URINE LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25791387 ↗
• MalfunctionJul 12, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25791371 ↗
• MalfunctionJul 12, 2026Material Invagination

  IT WAS REPORTED THAT THE BALLOON HAD COMPLETELY DEFLATED AND A FOLD AT THE BALLOON LEVEL WAS VISIBLE AFTER REMOVAL ,2 OTHER CATHETERS WERE TESTED, AND THE BALLOON FOLDED EACH TIME, THIS ISSUE HAD BEEN RAISED IN 2025 BY ANOTHER SECTOR FOR THIS SAME PRODUCT. THE COMPLAINT WAS CANCELED AND NOT FORWARDED TO YOU BECAUSE THE STAFF HAD INFLATED THE BALLOON WITH 7ML INSTEAD OF THE INDICATED 5ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25791276 ↗
• MalfunctionJul 12, 2026Material Invagination

  Patient problems: Pain

  MAUDE report 25790403 ↗
• MalfunctionJul 8, 2026Material Puncture/Hole

  It was reported by the resource nurse with EMP, and the staff have been having some trouble with the bardex all silicone foley catheter size 16 with 5cc bulb. They are just falling out of patients according to the patient. Patient required replacement of 4 indwelling catheters and eventually, a latex catheter was placed. No other issue observed with the catheter. Upon testing current stock as well as other sizes and bulb sizes only one side of the catheter is inflating which is leaving the bulb lopsided which can then easily pull out. They have attached a photo of what the catheter looked like.Per additional information received on 07APR2026, it was reported it was 16 and 18 with 5ml bulb and 16 and 18 with 30ml bulb". They called the customer to clarify this information. A 16 and 18Fr catheter were inserted into the patient and fell out the same day. The customer inflated a 16, 18 Fr with 5cc balloon and 16,18Fr 30cc balloon at their desk and the balloons only inflated mostly on one side. They sent the Foley Inflation/Deflation instruction sheet and asked if they followed the instructions when inflating and they said they did. Asked to send a container and prepaid label and They w

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25752802 ↗
• MalfunctionJun 5, 2026Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT SEVERAL DAYS AFTER PLACEMENT A SOUND OF RUPTURE WAS HEARD WHILE THE DEVICE WAS IN PLACE IN THE PATIENT; UPON CHECKING, THE FOLEY CATHETER FELL OUT, THE LOCATION IS UNKNOWN, AS IT COULD NOT BE VISUALLY CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411071 ↗
• MalfunctionMar 15, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BALLOON DEFLATED AND IT DISLODGED BY ITSELF WITHOUT CLINICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602038 ↗
• MalfunctionMar 13, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT A BARDEX 14 FRENCH FOLEY CATHETER HAD BEEN INSERTED. IT IMMEDIATELY BEGAN LEAKING FROM WHAT APPEARED TO BE A CRACK IN THE TUBING WHERE THE INSERTED PORTION MET THE WIDER PORTION USED TO ATTACH TO THE DRAINAGE TUBING. THE CATHETER NEEDED TO BE REMOVED, AND NO FOLEY WAS REINSERTED DUE TO THE PATIENT EXPERIENCING PAIN AND BLEEDING WITH REPEATED INSERTION ATTEMPTS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 24599409 ↗
• MalfunctionMar 2, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING USE A FEW RANDOM FOLEY CATHETERS WERE ADMINISTERED AND UPON REGULAR CHECK BY NURSES REALIZED THAT THE CATHETERS HAD DISLODGED AND THAT THE BALLOONS WERE DEFLATED WITHOUT CLINICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24488702 ↗
• MalfunctionFeb 17, 2026Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT A FOLEY CATHETER HAD BEEN PLACED IN THE PATIENT¿S BLADDER FOLLOWING CSC PLACEMENT. WHEN THE FOLEY CATHETER WAS INFLATED, THE PLASTIC/SILICONE MATERIAL AT THE BIFURCATION OF THE CATHETER HAD RIPPED, CAUSING WATER TO SPRAY ONTO THE MEDICAL PROVIDERS DURING THE FOLEY BULB INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370219 ↗
• MalfunctionJan 23, 2026Material Puncture/Hole; Difficult to Remove

  IT WAS REPORTED THAT THE 9CC OF SALINE CAME OUT OF THE FOLEY BALLOON AFTER 10 WAS INSERTED. THE FOLEY CATHETER WOULD NOT PULL OUT OF THE URETHRA. THESE ARE THE DATE: 2 OCCURRED ON AND 1 ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24166885 ↗
• MalfunctionJan 23, 2026Material Puncture/Hole; Difficult to Remove

  IT WAS REPORTED THAT THE 9CC OF SALINE CAME OUT OF THE FOLEY BALLOON AFTER 10 WAS INSERTED. THE FOLEY CATHETER WOULD NOT PULL OUT OF THE URETHRA. THESE ARE THE DATES: 2 OCCURRED ON (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24166883 ↗
• MalfunctionJan 12, 2026Material Puncture/Hole; Difficult to Remove

  IT WAS REPORTED THAT THE 9CC OF SALINE CAME OUT OF THE BALLOON AFTER 10 WAS INSERTED. THE FOLEY CATHETER WOULD NOT PULL OUT OF THE URETHRA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031541 ↗
• MalfunctionJan 8, 2026Difficult to Remove

  IT WAS REPORTED THAT THE 9CC OF SALINE CAME OUT OF THE BALLOON AFTER 10 WAS INSERTED. THE FOLEY WOULD NOT PULL OUT OF THE URETHRA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24015460 ↗
• MalfunctionJan 8, 2026Material Puncture/Hole; Difficult to Remove

  IT WAS REPORTED THAT THE ¿9CC OF SALINE CAME OUT OF THE BALLOON AFTER 10 WAS INSERTED. THE FOLEY WOULD NOT PULL OUT OF THE URETHRA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24013708 ↗
• MalfunctionDec 30, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ONE WEEK AFTER PLACEMENT THE FOLEY CATHETER HAD SPONTANEOUSLY COME OUT WHILE BEING MANAGED AT HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930101 ↗
• MalfunctionDec 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PLACEMENT, FOLEY CATHETER FUNNEL SECTION WAS FRACTURED DURING PATIENT TRANSFER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23890467 ↗
• MalfunctionDec 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN FLUSHING SALINE, THE CONNECTED HAD A HOLE IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822581 ↗
• MalfunctionDec 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE NURSE PLACED A FOLEY PRIOR TO THEIR SCHEDULED CESAREAN SECTION PER PROTOCOL. NURSE FILLED THE FOLEY BULB WITH 10ML AND URINE DRAINED FREELY THROUGHOUT CASE. SHORTLY AFTER RETURNING TO THE PATIENT¿S ROOM POSTOPERATIVELY, THE FOLEY FELL OUT AND THE BULB WAS DEFLATED. TO TROUBLESHOOT, I FILLED THE BALLOON AGAIN WITH 10ML OF WATER. THE BALLOON FILLED ALL THE WAY, THEN SLOWLY DEFLATED OVER A COUPLE MINUTES. THE FLUID WAS SLOWLY LEAKING FROM THE OPENING OF THE CATHETER TIP, BUT THE EXTERNAL BALLOON APPEARED INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778294 ↗
• MalfunctionDec 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FLUSH USED FOR THE CATHETER BALLOON CAUSED A SMALL TEAR IN THE EXTERNAL MAIN HUB OF THE DEVICE. CONSEQUENTLY, THE CATHETER WAS IMMEDIATELY REMOVED, AND A NEW FOLEY CATHETER WAS PLACED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23762892 ↗
• MalfunctionDec 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE INFLATING FOLEY BALLOON ON INSERTION, SALINE NOTED TO BE LEAKING THROUGH A HOLE NEAR THE Y JUNCTION. UNABLE TO INFLATE BALLOON AT TIP OF CATHETER AS A RESULT OF THE LEAK, AND FOLEY HAD TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735399 ↗
• MalfunctionDec 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED AT 12:00 ON (B)(6). AT 1:00 ON (B)(6) DUE TO PATIENT POSITIONING, THEY CHECKED AND DISCOVERED THAT THE DEVICE HAD SPONTANEOUSLY REMOVED. THE SHAFT AND FUNNEL AREAS WERE WET, SO THEY INJECTED STERILE DISTILLED WATER AND DISCOVERED A STERILE WATER LEAK NEAR THE JUNCTION BETWEEN THE SHAFT AND FUNNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735158 ↗
• MalfunctionNov 26, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON RUPTURED UPON INSERTION WHEN USING SYRINGE TO INFLATE BALLOON AND LEAKING NOTED AT Y PORT OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657708 ↗