Bardex® Lubricath® Foley Catheter Edelman Model 087016Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741039232), received between May 7, 2019 and Jun 16, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT URETERAL CATHETERS HAD A HAIR IN THE STERILE PACKAGE. PER FOLLOW-UP VIA EMAIL ON 01JUN2023, THE PRODUCT NEVER TOUCHED THE STERILE FIELD, SO NO HARM OR POTENTIAL HARM CAME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17143860 ↗
• MalfunctionDec 27, 2019Use of Device Problem; Leak/Splash; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT DURING THE INVESTIGATION, IT WAS FOUND DURING TESTING THAT WHEN THERE WAS A LEAKING PROBLEM IN THE PORTS. PER MS&S THE URETERAL CATHETERS, NOT STENTS WERE USED IN THE EDELMAN CATHETER AND THE PLUGS PLACED INTO THE CATHETER PORTS WERE AN OFF-LABEL USE THAT COULD POTENTIALLY DEFORM THE CATHETER.

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

  MAUDE report 9526049 ↗
• MalfunctionSep 27, 2019Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A EDELMAN CATHETER WAS PLACED ON (B)(6) 2019 AND IT WAS NOTED THAT URINE WAS LEAKING FROM THE Y-PORT WHERE THE URETHRAL STENT WAS REMOVED. THE CATHETER WAS NOT REMOVED FROM THE PATIENT PER THE SURGEON. THE NURSING STAFF MADE STERILE PLUGS FROM IV CAP SUPPLIES FOR THE LEAKING URETHRAL PORTS THAT WERE ON THE FOLEY. THE CATHETER WAS REMOVED FROM THE PATIENT ON (B)(6) 2019. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9129676 ↗
• MalfunctionJul 31, 2019Partial Blockage; Partial Blockage; Complete Blockage; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE FOLEY CATHETER PREMATURELY DEFLATED UPON REMOVAL FROM THE PATIENT. THE COMPLAINANT ADVISED THAT 'SALINE" WAS USED TO INFLATE THE FOLEY. THE COMPLAINANT ADVISED VIA EMAIL ON (B)(6) 2019 THAT SHE WAS MISTAKEN ABOUT THE USE OF SALINE AND THAT THE FOLEY WAS INFLATED WITH STERILE WATER.

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

  MAUDE report 8848210 ↗
• MalfunctionJul 26, 2019Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON OF THE EDELMAN FOLEY CATHETER WOULD NOT DEFLATE. IT WAS UNKNOWN HOW THE BALLOON WAS DEFLATED FOR REMOVAL. THE PATIENT DID EXPERIENCE LOCALIZED BLEEDING. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 8833555 ↗
• MalfunctionJul 26, 2019Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THERE WAS URINE LEAKAGE FROM THE PORTS THAT THE URETERAL CATHETERS ARE PULLED OUT OF ON THE FOLEY. THE FOLEY WAS EXCHANGED AND ONE WAS USED ON THE PATIENT THAT DID NOT HAVE THE URETERAL PORTS.

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

  MAUDE report 8831518 ↗
• MalfunctionJul 16, 2019Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE AND WOULD NOT DEFLATE. THE SURGEON INSERTED POLLOCKS AND THE EDELMAN FOLEY PRIOR TO THE SURGEON PORTION OF THE PROCEDURE. ORDERS WERE GIVEN TO REMOVE POLLOCKS AND INSERT REGULAR FOLEY AT THE COMPLETION OF THE CASE. AFTER COMPLETION OF THE CASE, THE NURSE ATTEMPTED TO REMOVE THE FOLEY; THE POLLOCKS WERE REMOVED WITHOUT DIFFICULTIES AND INTACT. THE FOLEY BALLOON WOULD NOT COLLAPSE. THE NURSE CUT A SUTURE TIED AROUND THE FOLEY AND THAT DID NOT MAKE A CHANGE. SEVERAL ATTEMPTS WERE MADE TO RETRACT WATER FROM BALLOON WITHOUT SUCCESS. THE SURGEON THEN ATTEMPTED THE SAME PROCEDURAL ROUTINE WITH NO SUCCESS; THE SURGEON THEN CUT THE FOLEY HOPING TO DRAIN BALLOON, WITH NO SUCCESS. FINALLY, THE SURGEON WAS ABLE TO MANUALLY FEEL THAT THE BALLOON WAS NOT DEFLATED. THE FOLEY CAME OUT WITH MANUAL HELP FROM SURGEON. THE BALLOON WAS STILL INTACT, AND STILL FULL OF WATER. AFTER OUTSIDE OF THE PATIENT, THE SURGEON AND NURSE ATTEMPTED TO EMPTY THE BALLOON JUST AS A TROUBLE SHOOTING METHOD, AFTER MANIPULATION AND CUTTING. THE BALLOON STILL REMAINED WITH WATER IN IT, AND INTACT. THE PATIENT WAS EXAMINED VIA SURGEON AND THE NURSE; THERE WAS NO BLEE

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

  MAUDE report 8793607 ↗
• MalfunctionMay 7, 2019Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER PREMATURELY DEFLATED UPON REMOVAL FROM THE PATIENT. THE COMPLAINANT ADVISED THAT SALINE WAS USED TO INFLATE THE FOLEY. THE COMPLAINANT ADVISED VIA EMAIL ON 23-APRIL-2019 THAT SHE WAS MISTAKEN ABOUT THE USE OF SALINE AND THAT THE FOLEY WAS INFLATED WITH STERILE WATER.

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

  MAUDE report 8585883 ↗