RUSCH IPN039296Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 14026704661777), received between Sep 6, 2022 and Jun 8, 2023 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE IN USE, THE BELLY BAG IS "LEAKING FROM WHERE THE INLET TUBE MEETS THE BAG". ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT HARM OR INJURY, OR MEDICAL INTERVENTION REQUIRED. THE ISSUE WAS RESOLVED BY CHANGING THE BAG. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088091 ↗
• MalfunctionJun 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE IN USE, THE BELLY BAG IS "LEAKING FROM WHERE THE INLET TUBE MEETS THE BAG". ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT HARM OR INJURY, OR MEDICAL INTERVENTION REQUIRED. THE ISSUE WAS RESOLVED BY CHANGING THE BAG. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079671 ↗
• MalfunctionMay 4, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE BAG LEAKED OUT AT THE 90-DEGREE INTAKE WHERE THE CATHETER CONNECTS". 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.

  Patient problems: Insufficient Information

  MAUDE report 16872711 ↗
• MalfunctionMay 4, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE BAG LEAKED OUT AT THE 90-DEGREE INTAKE WHERE THE CATHETER CONNECTS". 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.

  Patient problems: Insufficient Information

  MAUDE report 16872668 ↗
• MalfunctionApr 18, 2023Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER CALLED TO REPORT THAT THE "BELLY BAGS SHE PURCHASED ONLINE RECENTLY APPEAR TO HAVE CHANGED FROM WHAT SHE HAS RECEIVED IN THE 10+ YEARS OF USE. SHE NOTES THAT THE DRAIN VALVE IS MUCH MORE DIFFICULT TO TWIST AND THAT THE DRAIN TUBE ALSO SEEMS TO BE A LITTLE LONGER". NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763697 ↗
• MalfunctionApr 18, 2023Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER CALLED TO REPORT THAT THE "BELLY BAGS SHE PURCHASED ONLINE RECENTLY APPEAR TO HAVE CHANGED FROM WHAT SHE HAS RECEIVED IN THE 10+ YEARS OF USE. SHE NOTES THAT THE DRAIN VALVE IS MUCH MORE DIFFICULT TO TWIST AND THAT THE DRAIN TUBE ALSO SEEMS TO BE A LITTLE LONGER". NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763678 ↗
• MalfunctionApr 18, 2023Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER CALLED TO REPORT THAT THE "BELLY BAGS SHE PURCHASED ONLINE RECENTLY APPEAR TO HAVE CHANGED FROM WHAT SHE HAS RECEIVED IN THE 10+ YEARS OF USE. SHE NOTES THAT THE DRAIN VALVE IS MUCH MORE DIFFICULT TO TWIST AND THAT THE DRAIN TUBE ALSO SEEMS TO BE A LITTLE LONGER". NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763663 ↗
• MalfunctionApr 5, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE DRAIN VALVE IS NOT WORKING PROPERLY. SEE ASSOCIATE MDRS 3011137372-2023-00097, 3011137372-2023-00098.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682176 ↗
• MalfunctionApr 5, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE DRAIN VALVE IS NOT WORKING PROPERLY. SEE ASSOCIATE MDRS 3011137372-2023-00097, 3011137372-2023-00099

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682151 ↗
• MalfunctionApr 5, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE DRAIN VALVE IS NOT WORKING PROPERLY. SEE ASSOCIATE MDRS 3011137372-2023-00098, 3011137372-2023-00099

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682101 ↗
• MalfunctionMar 10, 2023Improper Flow or Infusion; Improper Flow or Infusion

  REPORTED ISSUE: URINE WILL NOT GO INTO THE BAGS. NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16524762 ↗
• MalfunctionMar 10, 2023Improper Flow or Infusion; Improper Flow or Infusion

  REPORTED ISSUE: URINE WILL NOT GO INTO THE BAGS. NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16524701 ↗
• MalfunctionDec 22, 2022Leak/Splash; Leak/Splash

  REPORTED ISSUE: JUST HAD ANOTHER BELLY BAG LEAK IN THE FIRST WEEK. THIS TIME IT WAS A FAULTY VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16038371 ↗
• MalfunctionNov 18, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTED ISSUE: CUSTOMER REPORTED THE DRAIN VALVES ARE FROZEN, WAY TOO STIFF, CANNOT BE OPENED. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827246 ↗
• MalfunctionOct 29, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PATIENT STATES HE IS HAVING AN ISSUE WITH HIS BELLY BAGS LEAKING AND DIFFICULTY OPENING THE DRAIN VALVE. HE STATED THAT ONE LASTED FOR 2 DAYS, ONE FOR 1 DAY AND THE LAST ONE LASTED ONLY 6 HOURS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696641 ↗
• MalfunctionOct 29, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PATIENT STATES HE IS HAVING AN ISSUE WITH HIS BELLY BAGS LEAKING AND DIFFICULTY OPENING THE DRAIN VALVE. HE STATED THAT ONE LASTED FOR 2 DAYS, ONE FOR 1 DAY AND THE LAST ONE LASTED ONLY 6 HOURS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695032 ↗
• MalfunctionOct 28, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PATIENT STATES HE IS HAVING AN ISSUE WITH HIS BELLY BAGS LEAKING AND DIFFICULTY OPENING THE DRAIN VALVE. HE STATED THAT ONE LASTED FOR 2 DAYS, ONE FOR 1 DAY AND THE LAST ONE LASTED ONLY 6 HOURS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692367 ↗
• MalfunctionOct 17, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  THE CUSTOMER CALLED TO REPORT THAT THE LAST SEVERAL BAGS WITH THIS LOT NUMBER HAVE BEEN VERY POOR QUALITY AND BASICALLY UNUSABLE. THE BUCKLE HAS BEEN CHANGED AND IS EXTREMELY HARD TO OPEN; SHE HAD TO CUT 2 BAGS OFF BECAUSE THE BUCKLE WOULD NOT OPEN, THE VINYL USED IS VERY THIN AND TEARS, AND THE TUBE RUNNING FROM THE BAG TO THE DRAIN SPOUT IS NOW LONGER AND VERY SOFT. THE TWIST SPOUT IS ALSO MUCH STIFFER AND HARD TO OPEN. SHE IS VERY DISAPPOINTED IN THE QUALITY SINCE MANUFACTURING HAS MOVED. SHE HAS USED THE BELLY BAG FOR APPROXIMATELY 8 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614877 ↗
• MalfunctionSep 27, 2022Use of Device Problem; Use of Device Problem

  THE PART OF THIS EVENT THAT IS REPORTABLE PERTAINS TO THE BELLY BAG NOT DRAINING. THE CUSTOMER SAID THAT THE LATCH WILL NOT STAY LATCHED. THE BUCKLE DOES NOT SLIDE TO ADJUST THE BELT. THE INNER FLAP NEXT TO THE CATHETER ENTRY IS LARGER SO THE BAG GETS PLUGGED OFTEN. CANNOT DRAIN INTO A BAG. BAG MATERIAL IS VERY THIN AND TEARS EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491116 ↗
• MalfunctionSep 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  JUST OPENED 4 MORE OF THE RUSCH BELLY BAGS AND AGAIN DIFFICULTY OPENING AND CLOSING THE OPENING FOR URINE DRAINAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362807 ↗
• MalfunctionSep 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  JUST OPENED 4 MORE OF THE RUSCH BELLY BAGS AND AGAIN DIFFICULTY OPENING AND CLOSING THE OPENING FOR URINE DRAINAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362802 ↗
• MalfunctionSep 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  JUST OPENED 4 MORE OF THE RUSCH BELLY BAGS AND AGAIN DIFFICULTY OPENING AND CLOSING THE OPENING FOR URINE DRAINAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362757 ↗
• MalfunctionSep 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  JUST OPENED 4 MORE OF THE RUSCH BELLY BAGS AND AGAIN DIFFICULTY OPENING AND CLOSING THE OPENING FOR URINE DRAINAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362621 ↗