CURE CATHETER CLOSED SYSTEM CS12Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00815947020666), received between Aug 23, 2022 and Mar 24, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (19 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681889 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681867 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681793 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681703 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681676 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681656 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681604 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681551 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676217 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676207 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675893 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675839 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675760 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675708 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675707 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675706 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675546 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675479 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Packaging Problem

  IT WAS REPORTED BY THE MOTHER OF A 25 YO FEMALE THAT THE BAG PORTION OF THE CATHETER IS STUCK IN INDIVIDUAL PACKAGING SEALS. THE CONSUMER HAS CATH'D WITH THIS PRODUCT FOR 8 YRS NOW AND CATHS THROUGH HER URETHRA. SHE GETS 200 CATHETERS PER MONTH, 2 CASES. SHE REPORTS THAT SHE HAS FOUND 20 CATHETERS THAT HAVE THIS SAME DEFECT. BOTH CASES HAVE THE SAME LOT AND THESE 20 HAVE COME FROM BOTH CASES SO FAR. SHE SAID THE BAG OF THE CATHETER ITSELF IS STUCK IN THE SIDE HEAT SEAL OF THE CATHETERS INDIVIDUAL PACKAGING. SHE SAID IT TENDS TO BE STUCK ON THE BOTTOM OF THE BAG TO THE BOTTOM SEAL OF THE PACKAGING. IF SHE PULLS THE BAG OUT, IT WILL TEAR THE CATHETER'S BAG. THEY HAVE NOT USED ONES LIKE THIS WITH THE REPORTED DEFECT AND THE MAJORITY HAVE BEEN DISCARDED BUT SHE SAID SHE HAS KEPT 2 WITH THE DEFECT AND CAN SEND PHOTOS OF THE CONCERN. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675478 ↗
• MalfunctionAug 23, 2022Premature Separation; Premature Separation

  END USER'S GRANDMOTHER REPORTS "SHE CATHS HIM 4 X A DAY AS HE WAS IN AN AUTOMOBILE ACCIDENT RESULTING HIM QUADRIPLEGIA AND NO FEELING OF HIS BLADDER AND SHE CATHS HIM 4 X A DAY FOR RETENTION. SHE REPORTS FOR THE CS12, THE DEFECT SHE REPORTS IS THAT THE CATHETER TIP IS NOT IN THE BLUE GUIDE PART, IT IS FLOATING IN THE BAG MAKING IT UNUSABLE - SHE REPORTS UNKNOWN QTY OF DEFECTED CATHETERS, "MAYBE 1 OR 2 A MONTH FOR ABOUT THE LAST 6 MONTHS" FROM UNKNOWN MU/S OF UNKNOWN LOTS. CURRENT MU BOX SHE JUST FOUND QTY 2 AFFECTED CATHETERS IS OF LOT # 220222-2. SHE STATES SHE DISCARDS THEM AS THEY ARE UNUSABLE. SHE SAID SHE HAS NOTICED THIS START TO OCCUR ONLY FOR ABOUT THE LAST 6 MONTHS OR SO WITH MAYBE 1 OR 2 A MONTH SHE FINDS LIKE THIS OF THESE CATHETERS. SHE SAID SHE CANNOT USE AS THEY ARE UNUSABLE AS NO WAY FOR HER TO GET IN HIS PENIS. SHE SAID SHE CANNOT MAKE THE CATHETER TIP FLOATING IN BAG GO IN THE BLUE GUIDE WITHOUT OPENING THE BAG AND SHE DIDN'T THINK IT WOULD BE GOOD FOR HER TO OPEN THE BAG AND CONTAMINATE IT BECAUSE SHE KNOWS IT IS STERILE." SHE WAS ADVISED TO CONTINUE TO "NOT USE AND SHE DID THE CORRECT THING BY NOT USING CATHETERS SHE FINDS LIKE THIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15275773 ↗
• MalfunctionAug 23, 2022Premature Separation; Premature Separation

  END USER'S GRANDMOTHER REPORTS "SHE CATHS HIM 4 X A DAY AS HE WAS IN AN AUTOMOBILE ACCIDENT RESULTING HIM QUADRIPLEGIA AND NO FEELING OF HIS BLADDER AND SHE CATHS HIM 4 X A DAY FOR RETENTION. SHE REPORTS FOR THE CS12, THE DEFECT SHE REPORTS IS THAT THE CATHETER TIP IS NOT IN THE BLUE GUIDE PART, IT IS FLOATING IN THE BAG MAKING IT UNUSABLE - SHE REPORTS UNKNOWN QTY OF DEFECTED CATHETERS, "MAYBE 1 OR 2 A MONTH FOR ABOUT THE LAST 6 MONTHS" FROM UNKNOWN MU/S OF UNKNOWN LOTS. CURRENT MU BOX SHE JUST FOUND QTY 2 AFFECTED CATHETERS IS OF LOT # 220222-2. SHE STATES SHE DISCARDS THEM AS THEY ARE UNUSABLE. SHE SAID SHE HAS NOTICED THIS START TO OCCUR ONLY FOR ABOUT THE LAST 6 MONTHS OR SO WITH MAYBE 1 OR 2 A MONTH SHE FINDS LIKE THIS OF THESE CATHETERS. SHE SAID SHE CANNOT USE AS THEY ARE UNUSABLE AS NO WAY FOR HER TO GET IN HIS PENIS. SHE SAID SHE CANNOT MAKE THE CATHETER TIP FLOATING IN BAG GO IN THE BLUE GUIDE WITHOUT OPENING THE BAG AND SHE DIDN'T THINK IT WOULD BE GOOD FOR HER TO OPEN THE BAG AND CONTAMINATE IT BECAUSE SHE KNOWS IT IS STERILE." SHE WAS ADVISED TO CONTINUE TO "NOT USE AND SHE DID THE CORRECT THING BY NOT USING CATHETERS SHE FINDS LIKE THIS." THIS EMDR COVERS THE UNKNOWN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15275771 ↗
• MalfunctionAug 23, 2022Premature Separation; Premature Separation

  END USER'S GRANDMOTHER REPORTS "SHE CATHS HIM 4 X A DAY AS HE WAS IN AN AUTOMOBILE ACCIDENT RESULTING HIM QUADRIPLEGIA AND NO FEELING OF HIS BLADDER AND SHE CATHS HIM 4 X A DAY FOR RETENTION. SHE REPORTS FOR THE CS12, THE DEFECT SHE REPORTS IS THAT THE CATHETER TIP IS NOT IN THE BLUE GUIDE PART, IT IS FLOATING IN THE BAG MAKING IT UNUSABLE - SHE REPORTS UNKNOWN QTY OF DEFECTED CATHETERS, "MAYBE 1 OR 2 A MONTH FOR ABOUT THE LAST 6 MONTHS" FROM UNKNOWN MU/S OF UNKNOWN LOTS. CURRENT MU BOX SHE JUST FOUND QTY 2 AFFECTED CATHETERS IS OF LOT # 220222-2. SHE STATES SHE DISCARDS THEM AS THEY ARE UNUSABLE. SHE SAID SHE HAS NOTICED THIS START TO OCCUR ONLY FOR ABOUT THE LAST 6 MONTHS OR SO WITH MAYBE 1 OR 2 A MONTH SHE FINDS LIKE THIS OF THESE CATHETERS. SHE SAID SHE CANNOT USE AS THEY ARE UNUSABLE AS NO WAY FOR HER TO GET IN HIS PENIS. SHE SAID SHE CANNOT MAKE THE CATHETER TIP FLOATING IN BAG GO IN THE BLUE GUIDE WITHOUT OPENING THE BAG AND SHE DIDN'T THINK IT WOULD BE GOOD FOR HER TO OPEN THE BAG AND CONTAMINATE IT BECAUSE SHE KNOWS IT IS STERILE." SHE WAS ADVISED TO CONTINUE TO "NOT USE AND SHE DID THE CORRECT THING BY NOT USING CATHETERS SHE FINDS LIKE THIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15275767 ↗