Bardex® All-Silicone Foley Catheter 165822Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741029783), received between Jan 30, 2018 and Oct 30, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE CUSTOMER IS SEEKING FULL CREDIT ON AN ORDER OF FOLEY CATHETERS DUE TO MANUFACTURING DEFECTS. THEY HAVE ONLY RECENTLY DISCOVERED. DUE TO THE NATURE OF CATHETER PACKAGING, IT IS IMPOSSIBLE TO INSPECT THE CATHETERS UPON RECEIPT TO IDENTIFY SUCH DEFECTS WHILE MAINTAINING THEIR STERILITY. ON ORDER (B)(4) FROM (B)(6) 2024, THE CUSTOMER RECEIVED TWO CASES OF BARDEX FOLEY CATHETER, PART 165822, FROM WHAT APPEARS TO BE A DEFECTIVE LOT. ROUGHLY 7 OF THE 12 CATHETERS HAD EITHER SURFACE DEFECTS (BURRS) OR HAD LOOSE FLAPS OF SILICONE STUCK TO THEM. FIVE OF THESE CATHETERS CAUSED MINOR INTERNAL TRAUMA OR IRRITATION, IN THREE CASES PRODUCING BLOOD UPON REMOVAL. THEY DID NOT USE THE LAST TWO CATHETERS FROM THIS CASE, AND INSTEAD THEY OPENED THEM UP AND FOUND ONE WITH A LOOSE FLAP OF SILICONE (SEE PHOTO). THE DEFECTIVE LOT IS NGJV0914. THE CUSTOMER HAS ONE REMAINING CASE OF 12 CATHETERS FROM THIS LOT. THE CUSTOMER CANNOT USE IT DUE TO THE SUBSTANTIAL MANUFACTURING DEFECTS IN ITS SIBLING CASE. THE PATIENT WISHES TO RETURN THIS CASE TO YOU FOR FULL CREDIT AND SO YOU CAN FORWARD IT TO BARD FOR ANY INVESTIGATION THEY CARE TO PERFORM. DEFECTS IN CATHETERS ARE IMPORTANT ENOUGH TH

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

  MAUDE report 23427698 ↗
• MalfunctionOct 30, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER IS SEEKING FULL CREDIT ON AN ORDER OF FOLEY CATHETERS DUE TO MANUFACTURING DEFECTS. THEY HAVE ONLY RECENTLY DISCOVERED. DUE TO THE NATURE OF CATHETER PACKAGING, IT IS IMPOSSIBLE TO INSPECT THE CATHETERS UPON RECEIPT TO IDENTIFY SUCH DEFECTS WHILE MAINTAINING THEIR STERILITY. ON ORDER (B)(4) FROM (B)(6) 2024, THE CUSTOMER RECEIVED TWO CASES OF BARDEX FOLEY CATHETER, PART 165822, FROM WHAT APPEARS TO BE A DEFECTIVE LOT. ROUGHLY 7 OF THE 12 CATHETERS HAD EITHER SURFACE DEFECTS (BURRS) OR HAD LOOSE FLAPS OF SILICONE STUCK TO THEM. FIVE OF THESE CATHETERS CAUSED MINOR INTERNAL TRAUMA OR IRRITATION, IN THREE CASES PRODUCING BLOOD UPON REMOVAL. THEY DID NOT USE THE LAST TWO CATHETERS FROM THIS CASE, AND INSTEAD THEY OPENED THEM UP AND FOUND ONE WITH A LOOSE FLAP OF SILICONE. THE DEFECTIVE LOT IS NGJV0914. THE CUSTOMER HAS ONE REMAINING CASE OF 12 CATHETERS FROM THIS LOT. THE CUSTOMER CANNOT USE IT DUE TO THE SUBSTANTIAL MANUFACTURING DEFECTS IN ITS SIBLING CASE. THE PATIENT WISHES TO RETURN THIS CASE TO YOU FOR FULL CREDIT AND SO YOU CAN FORWARD IT TO BARD FOR ANY INVESTIGATION THEY CARE TO PERFORM. DEFECTS IN CATHETERS ARE IMPORTANT ENOUGH THAT THE FDA T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427663 ↗
• MalfunctionOct 30, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE PT EMAIL SENT TO CHAH READS I AM SEEKING FULL CREDIT ON AN ORDER OF FOLEY CATHETERS DUE TO MANUFACTURING DEFECTS I HAVE ONLY RECENTLY DISCOVERED. DUE TO THE NATURE OF CATHETER PACKAGING, IT IS IMPOSSIBLE TO INSPECT THE CATHETERS UPON RECEIPT TO IDENTIFY SUCH DEFECTS WHILE MAINTAINING THEIR STERILITY. ON MY ORDER (B)(4) FROM (B)(6)2024, I RECEIVED TWO CASES OF BARDEX FOLEY CATHETER, PART 165822, FROM WHAT APPEARS TO BE A DEFECTIVE LOT. ROUGHLY 7 OF THE 12 CATHETERS HAD EITHER SURFACE DEFECTS (BURRS) (SEE PHOTO) OR HAD LOOSE FLAPS OF SILICONE STUCK TO THEM. FIVE OF THESE CATHETERS CAUSED MINOR INTERNAL TRAUMA OR IRRITATION, IN THREE CASES PRODUCING BLOOD UPON REMOVAL. I DID NOT USE THE LAST TWO CATHS FROM THIS CASE, AND INSTEAD I OPENED THEM UP AND FOUND ONE WITH A LOOSE FLAP OF SILICONE (SEE PHOTO) THE DEFECTIVE LOT IS NGJV0914 (SEE PHOTO). I HAVE ONE REMAINING CASE OF 12 CATHETERS FROM THIS LOT. I CANNOT USE IT DUE TO THE SUBSTANTIAL MANUFACTURING DEFECTS IN ITS SIBLING CASE. I WISH TO RETURN THIS CASE TO YOU FOR FULL CREDIT AND SO YOU CAN FORWARD IT TO BARD FOR ANY INVESTIGATION THEY CARE TO PERFORM. DEFECTS IN CATHETERS ARE IMPORTANT ENOUGH THAT THE FDA T

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

  MAUDE report 23426687 ↗
• MalfunctionOct 30, 2025Nonstandard Device; Material Protrusion/Extrusion; Nonstandard Device; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE CUSTOMER IS SEEKING FULL CREDIT ON AN ORDER OF FOLEY CATHETERS DUE TO MANUFACTURING DEFECTS. THEY HAVE ONLY RECENTLY DISCOVERED. DUE TO THE NATURE OF CATHETER PACKAGING, IT IS IMPOSSIBLE TO INSPECT THE CATHETERS UPON RECEIPT TO IDENTIFY SUCH DEFECTS WHILE MAINTAINING THEIR STERILITY. ON ORDER (B)(4) FROM (B)(6) 2024, THE CUSTOMER RECEIVED TWO CASES OF BARDEX FOLEY CATHETER, PART 165822, FROM WHAT APPEARS TO BE A DEFECTIVE LOT. ROUGHLY 7 OF THE 12 CATHETERS HAD EITHER SURFACE DEFECTS (BURRS) OR HAD LOOSE FLAPS OF SILICONE STUCK TO THEM. FIVE OF THESE CATHETERS CAUSED MINOR INTERNAL TRAUMA OR IRRITATION, IN THREE CASES PRODUCING BLOOD UPON REMOVAL. THEY DID NOT USE THE LAST TWO CATHETERS FROM THIS CASE, AND INSTEAD THEY OPENED THEM UP AND FOUND ONE WITH A LOOSE FLAP OF SILICONE. THE DEFECTIVE LOT IS NGJV0914. THE CUSTOMER HAS ONE REMAINING CASE OF 12 CATHETERS FROM THIS LOT. THE CUSTOMER CANNOT USE IT DUE TO THE SUBSTANTIAL MANUFACTURING DEFECTS IN ITS SIBLING CASE. THE PATIENT WISHES TO RETURN THIS CASE TO YOU FOR FULL CREDIT AND SO YOU CAN FORWARD IT TO BARD FOR ANY INVESTIGATION THEY CARE TO PERFORM. DEFECTS IN CATHETERS ARE IMPORTANT ENOUGH THAT THE FDA T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426682 ↗
• InjuryMay 22, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE FOLEY CATHETER MATERIAL WAS DIFFERENT (SOFTER) WHICH INCREASED FALSE PATHS, WAS MORE DIFFICULT TO INSERT, WHICH HURT THE PATIENT. CUSTOMER HAD A SITUATION WHERE THE CATHETER HAD MADE A KNOT IN THE BLADDER, AND THEY HAD TO DO A CYSTOSCOPY TO CUT THE CATHETER WITH A LASER TO REMOVE IT (PCN#: 175812, PCN#: 175814, PCN#: 175816, PCN#: 175818, PCN#: 175820, PCN#: 165822 AND PCN#: 175824). PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 06MAY2025, THE TIP OF THE CATHETER THAT CONTAINS THE BALLOON IS PROMINENT AND FORMS A RING WHEN THE BALLOON IS DEFLATED. IT WAS ANOTHER ISSUE WITH THE DEFLATION OF THE BALLOON. THE BALLOON REMAINS DEFORMED WHEN DEFLATED, CAUSING INJURY TO THE PATIENT WHEN REMOVING THE INDWELLING CATHETER. THIS WAS APPARENTLY TRUE FOR ALL OUR 100% FOLEY (1658XX) AND LUBRI-SIL (1758XX) MODELS. (PCN#: 165820, PCN#: 165818 AND PCN#: 165816).

  Patient problems: Pain

  MAUDE report 22069846 ↗
• MalfunctionJul 25, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE IS A PINHOLE IN THE BALLOON DUE TO THAT STERILE WATER LEAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824566 ↗
• MalfunctionJun 6, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON ON THE SILICON FOLEY CATHETER WAS LEAKING AND BELIEVED THAT THE ITEMS WERE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481071 ↗
• MalfunctionMar 14, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CATHETER DISLODGED AND A NEW ONE HAD TO BE PLACED.

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

  MAUDE report 8420087 ↗
• MalfunctionMar 13, 2019Burst Container or Vessel; Device Dislodged or Dislocated; Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER DISLODGED AND A NEW ONE HAD TO BE PLACED.

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

  MAUDE report 8416477 ↗
• MalfunctionMar 13, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CATHETER DISLODGED AND A NEW ONE HAD TO BE PLACED.

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

  MAUDE report 8416097 ↗
• MalfunctionMar 13, 2018Deflation Problem; Component Falling; Deflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT DUE TO A DEFLATED BALLOON. WATER LEAKAGE WAS FOUND FROM THE LUMEN.

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

  MAUDE report 7335100 ↗
• MalfunctionJan 30, 2018Difficult to Open or Close

  IT WAS REPORTED THAT THE STATLOCK DEVICE WOULD NOT STAY CLOSED OVER THE 22FR SILICONE CATHETERS THE PATIENT USED. THE PATIENT REPORTED THAT THIS CAUSED THE STATLOCK DEVICE TO ROTATE DURING USE AND TWIST THE CATHETER, PREVENTING URINE FLOW.

  Patient problems: No Information

  MAUDE report 7229012 ↗