RUSCH IPN050977Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026704031870), received between Feb 23, 2022 and Feb 23, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2022Device Handling Problem; Sharp Edges; Device Handling Problem; Sharp Edges

  IT WAS REPORTED THAT: MY BROTHER HAS ISSUE WITH HIS URETHRA AND HE HAVE TO GO TO DOCTOR FOR CATHETERIZATION EVERY 2-3 WEEKS. HE IS BLEEDING AFTER THIS PROCEDURE. THEY PUT THE CATHETER IN AND INSTRUCTING HIM TO TAKE IT OUT IN DAY OR TWO. THEN HE NEEDS TO RETURN USED CATHETER BACK TO DOCTOR. MY QUESTION FOR YOU IS IF YOU LOOK AT THE PICTURES DO THE CATHETERS ORIGINALLY FROM YOUR FACTORY LOOKS LIKE THIS WITH THE CUT OUTS. IN OUR OPINION THESE LOOK LIKE THEY HAVE BEEN CUT OUT BY SOMEONE AT HOME? THE EDGES ARE SHARP RIGGED AND ALSO THE SPACE IS TOO CLOSE AND MAKE THE CATHETER TOO WEAK AND COLLAPSING AND THAT IN MY OPINION IS CAUSING THE BLEEDING FOLLOWED BY SWOLLEN PASSAGE IN URETHRA AND NECESSITY FOR REPEATED PROCEDURES. PLEASE LET ME KNOW IF THIS IS YOUR UNMODIFIED PRODUCT. I WOULD LIKE TO BRING THIS UP TO OUR UROLOGIST. NO DEVICE AVAILABLE FOR INVESTIGATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13584950 ↗