RUSCH IPN050511Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 14026704302205), received between Sep 27, 2022 and Jan 11, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT "PATIENT REPORTS THE BALLOON WOULD NOT DEFLATE FOR REMOVAL. USES A NEW CATHETER EVERY NIGHT. THIS HAS HAPPENED APPX. 3 MONTHS AGO AS WELL, BUT HE DID NOT REPORT IT-THOUGHT IT WAS JUST A 1 TIME ISSUE UNTIL IT HAPPENED THIS TIME". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDR #8040412-2024-00013.

  Patient problems: Insufficient Information

  MAUDE report 18497658 ↗
• MalfunctionJan 11, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT "PATIENT REPORTS THE BALLOON WOULD NOT DEFLATE FOR REMOVAL. USES A NEW CATHETER EVERY NIGHT. THIS HAS HAPPENED APPX. 3 MONTHS AGO AS WELL, BUT HE DID NOT REPORT IT-THOUGHT IT WAS JUST A 1 TIME ISSUE UNTIL IT HAPPENED THIS TIME". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDR #8040412-2024-00014.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495582 ↗
• MalfunctionJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE USER FOUND "SOMETHING STICKY ON ONE SIDE OF THE BALLOON NEAR THE BALLOON SEAT" PRIOR TO USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495454 ↗
• MalfunctionJun 28, 2023Deflation Problem; Deflation Problem

  IT IS REPORTED THAT "THE RETENTION BALLOON ON SEVERAL BALLOONS HAVE NOT DEFLATED. CLINICIAN RESORTED TO INTRODUCING MINERAL OIL TO ENABLE REMOVAL WHEN CUTTING THE SHAFT ALSO FAILED". ADDITIONAL INFORMATION RECEIVED STATES THAT THE NURSE ATTEMPTED TO REMOVE THE CATHETER BUT WAS UNABLE TO REMOVE THE FULL AMOUNT OF FLUID IN THE BALLOON. AS A RESULT MINERAL OIL WAS USED TO DEFLATE THE BALLOON. FURTHER INFORMATION STATES "ALL DEVICES WERE SEPARATE EVENTS. THE PATIENTS WERE FINE AFTER REMOVAL AS THE MAJORITY OF CASES WE WERE ABLE TO DEFLATE THE BALLOON WITH MINERAL OIL OR CUTTING OFF THE VALVE OR MAKING SLITS IN THE CATHETER. THE TWO PATIENTS THAT HAD THE CATHETER REMOVED WITH THE BALLOON PARTIALLY INFLATED DID NOT EXPERIENCE ANY COMPLICATIONS. NO DEVICES WERE REINSERTED. NO PATIENT REQUIRED RE-CATHETERIZATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217067 ↗
• MalfunctionJun 28, 2023Deflation Problem; Deflation Problem

  IT IS REPORTED THAT "THE RETENTION BALLOON ON SEVERAL BALLOONS HAVE NOT DEFLATED. CLINICIAN RESORTED TO INTRODUCING MINERAL OIL TO ENABLE REMOVAL WHEN CUTTING THE SHAFT ALSO FAILED". ADDITIONAL INFORMATION RECEIVED STATES THAT THE NURSE ATTEMPTED TO REMOVE THE CATHETER BUT WAS ONLY ABLE TO REMOVE 10ML OF THE 30ML BALLOON. AS A RESULT, THE CATHETER VALVE WAS CUT OFF AND AFTER APPROXIMATELY 2-3 HOURS, THE PATIENT STOOD UP AND THE CATHETER FELL OUT. FURTHER INFORMATION STATES "ALL DEVICES WERE SEPARATE EVENTS. THE PATIENTS WERE FINE AFTER REMOVAL AS THE MAJORITY OF CASES WE WERE ABLE TO DEFLATE THE BALLOON WITH MINERAL OIL OR CUTTING OFF THE VALVE OR MAKING SLITS IN THE CATHETER. THE TWO PATIENTS THAT HAD THE CATHETER REMOVED WITH THE BALLOON PARTIALLY INFLATED DID NOT EXPERIENCE ANY COMPLICATIONS. NO DEVICES WERE REINSERTED. NO PATIENT REQUIRED RE-CATHETERIZATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217014 ↗
• MalfunctionJun 28, 2023Deflation Problem; Deflation Problem

  IT IS REPORTED THAT "THE RETENTION BALLOON ON SEVERAL BALLOONS HAVE NOT DEFLATED. CLINICIAN RESORTED TO INTRODUCING MINERAL OIL TO ENABLE REMOVAL WHEN CUTTING THE SHAFT ALSO FAILED". ADDITIONAL INFORMATION RECEIVED STATES THAT THIS SITUATION ALSO OCCURRED DURING A "BCG PROCEDURE IN THE CLINIC" WHERE THE CATHETER IS ONLY IN PLACE FOR 10 MINUTES. FURTHER INFORMATION STATES "ALL DEVICES WERE SEPARATE EVENTS. THE PATIENTS WERE FINE AFTER REMOVAL AS THE MAJORITY OF CASES WE WERE ABLE TO DEFLATE THE BALLOON WITH MINERAL OIL OR CUTTING OFF THE VALVE OR MAKING SLITS IN THE CATHETER. THE TWO PATIENTS THAT HAD THE CATHETER REMOVED WITH THE BALLOON PARTIALLY INFLATED DID NOT EXPERIENCE ANY COMPLICATIONS. NO DEVICES WERE REINSERTED. NO PATIENT REQUIRED RE-CATHETERIZATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216905 ↗
• MalfunctionJun 28, 2023Deflation Problem; Deflation Problem

  IT IS REPORTED THAT "THE RETENTION BALLOON ON SEVERAL BALLOONS HAVE NOT DEFLATED. CLINICIAN RESORTED TO INTRODUCING MINERAL OIL TO ENABLE REMOVAL WHEN CUTTING THE SHAFT ALSO FAILED". ADDITIONAL INFORMATION RECEIVED STATES THAT THE STUDENT NURSE EMPTIED THE BULB AND THE VALVE COLLAPSED. THE INSTRUCTOR ASSUMED THE BULB WAS DEFLATED. WHEN THE CATHETER WAS REMOVED, THE BULB WAS STILL INTACT WITH 4-5ML OF FLUID. THE STUDENT NURSE DID NOT REALIZE THAT THE RESISTANCE THEY FELT REMOVING THE CATHETER WAS NOT NORMAL. FURTHER INFORMATION STATES "ALL DEVICES WERE SEPARATE EVENTS. THE PATIENTS WERE FINE AFTER REMOVAL AS THE MAJORITY OF CASES WE WERE ABLE TO DEFLATE THE BALLOON WITH MINERAL OIL OR CUTTING OFF THE VALVE OR MAKING SLITS IN THE CATHETER. THE TWO PATIENTS THAT HAD THE CATHETER REMOVED WITH THE BALLOON PARTIALLY INFLATED DID NOT EXPERIENCE ANY COMPLICATIONS. NO DEVICES WERE REINSERTED. NO PATIENT REQUIRED RE-CATHETERIZATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216793 ↗
• MalfunctionJun 28, 2023Deflation Problem; Deflation Problem

  IT IS REPORTED THAT "THE RETENTION BALLOON ON SEVERAL BALLOONS HAVE NOT DEFLATED. CLINICIAN RESORTED TO INTRODUCING MINERAL OIL TO ENABLE REMOVAL WHEN CUTTING THE SHAFT ALSO FAILED". ADDITIONAL INFORMATION RECEIVED STATES THAT THE NURSE WAS ONLY ABLE TO WITHDRAW A PARTIAL AMOUNT OF FLUID AND WAS UNABLE TO WITHDRAW THE REMAINING AMOUNT. THE NURSE USED "MINERAL OIL AND THE BULB POPPED". FURTHER INFORMATION STATES "ALL DEVICES WERE SEPARATE EVENTS. THE PATIENTS WERE FINE AFTER REMOVAL AS THE MAJORITY OF CASES WE WERE ABLE TO DEFLATE THE BALLOON WITH MINERAL OIL OR CUTTING OFF THE VALVE OR MAKING SLITS IN THE CATHETER. THE TWO PATIENTS THAT HAD THE CATHETER REMOVED WITH THE BALLOON PARTIALLY INFLATED DID NOT EXPERIENCE ANY COMPLICATIONS. NO DEVICES WERE REINSERTED. NO PATIENT REQUIRED RE-CATHETERIZATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216694 ↗
• MalfunctionJun 16, 2023Deflation Problem; Deflation Problem

  IT IS REPORTED THAT "THE RETENTION BALLOON ON SEVERAL BALLOONS HAVE NOT DEFLATED. CLINICIAN RESORTED TO INTRODUCING MINERAL OIL TO ENABLE REMOVAL WHEN CUTTING THE SHAFT ALSO FAILED". ADDITIONAL INFORMATION RECEIVED STATES THAT "THE NURSE WAS ABLE TO WITHDRAW 5ML FROM THE BULB AND THE VALVE COMPRESSED LIKE IT WAS DEFLATED. WE KNEW THERE WAS 10 IN THE BULB AS IT WAS DOCUMENTED IN THE RECORD. WE ATTEMPTED TO REMOVE THE REMAINING AMOUNT, BUT IT WOULD NOT RELEASE. I COULD ADD SW TO THE BULB, BUT NOT REMOVE IT. I ENDED UP CUTTING OFF THE VALVE AND STILL THE BULB REMAINED INFLATED IN THE BLADDER. WE ENDED UP PULLING IT OUT.". FURTHER INFORMATION STATES "ALL DEVICES WERE SEPARATE EVENTS. THE PATIENTS WERE FINE AFTER REMOVAL AS THE MAJORITY OF CASES WE WERE ABLE TO DEFLATE THE BALLOON WITH MINERAL OIL OR CUTTING OFF THE VALVE OR MAKING SLITS IN THE CATHETER. THE TWO PATIENTS THAT HAD THE CATHETER REMOVED WITH THE BALLOON PARTIALLY INFLATED DID NOT EXPERIENCE ANY COMPLICATIONS. NO DEVICES WERE REINSERTED. NO PATIENT REQUIRED RE-CATHETERIZATION." THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148234 ↗
• MalfunctionSep 27, 2022Deflation Problem; Deflation Problem

  A FOLEY CATHETER WAS INSTALLED IN THE PAVILION ON (B)(6)2022 IN A PATIENT UNDERGOING CESAREAN SECTION. ON DAY 30, WHEN TRYING TO REMOVE THE CATHETER, THE CUFF COULD NOT BE DEFLATED, ONLY 9 CC OF SERUM CAME OUT (CUFF INFLATED WITH 10 CC). CATHETER CAN BE REMOVED THIS IS THE THIRD INCIDENT WITH THIS BATCH ON THE SAME CLIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491496 ↗
• MalfunctionSep 27, 2022Deflation Problem; Deflation Problem

  A FOLEY CATHETER WAS INSTALLED IN THE PAVILION ON (B)(6) 2022 IN A PATIENT UNDERGOING CESAREAN SECTION. ON DAY 30, WHEN TRYING TO REMOVE THE CATHETER, THE CUFF COULD NOT BE DEFLATED, ONLY 9 CC OF SERUM CAME OUT (CUFF INFLATED WITH 10 CC). CATHETER CAN BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491418 ↗