GENTLECATH 421910Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 30768455153825), received between Dec 4, 2023 and Jul 20, 2026 — classified as 4 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (117 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 25 most recent of 122 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Sharp Edges

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25877086 ↗
• MalfunctionApr 27, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS, UNKNOWN QTY "ALMOST EVERYONE" IN 1 MU BOX, THE COUDE TIP AND NOTCH ON FUNNEL NOT ALIGNED CAUSING DISCOMFORT AND HAD BLEEDING WITH USE. CONSUMER HAS SELF CATH'D FOR THE PAST 6 MONTHS, OFF AND ON, WITH THIS PRODUCT. HE STATES HE HAS HAD 6 TOTAL SURGERIES FOR URETHRAL SCAR TISSUE AND TURP PROCEDURES IN HIS PAST. HIS MOST RECENT SURGERIES WERE IN OCTOBER OF LAST YEAR AND THIS YEAR ON (B)(6). HE STARTED CIC LAST YEAR AFTER HIS OCTOBER PROCEDURE AND HE WAS ADVISED TO START TO SELF -CATH ONCE EVERY DAY FOR A MONTH FOLLOWING THE PROCEDURE AND TAPERING DOWN FOR THE NEXT 2 MONTHS UNTIL STOPPING THE NEED TO CATH. HIS SCAR TISSUE RETURNED BADLY THIS YEAR AND NOW AFTER HIS MOST RECENT SURGERY IN FEB, HE HAS BEEN ADVISED BY HIS UROLOGIST TO CATH AT LEAST ONCE A DAY TO DRAIN BLADDER BUT ALSO TO KEEP SCAR TISSUE DILATED AND OPEN. HE NOTES THAT IN HIS RECENT BOX ALMOST EVERY CATHETER IN THE BOX WAS MISALIGNED BY ABOUT 45 DEGREES. HE SAID IF YOU LOOK AT THE LINE ON THE NOTCH ON THE FUNNEL ON TOP, THE COUDE TIP IS POINTING TO THE LEFT ABOUT 45 DEGREES. HE SAID PASSING THESE WITH MISALIGNMENT CAN CAUSE DISCOMFORT AND HE DID HAVE SOME BLEEDING THIS WEEK WITH USE OF THESE DAILY, NOTING

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25008554 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 24753196 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  END USER STATES "HE STARTED USING CG GLIDE IN 2022 AND LIKES THIS PRODUCT WORKS WELL FOR HIM. THIS YEAR HE WAS CONCERNED AS HE STATES HE HAS BEEN DIAGNOSED WITH 3 UTIS THUS FAR. HE SAID ON FEB 14TH HE HAD TO GO TO ER DUE TO EXCESSIVE BP READING AND HE WAS TOLD HE HAD A UTI BASED ON THE UA BUT THE URINE CULTURE DIDN'T GROW OUT ANY BACTERIA. DESPITE THIS, HE WAS TREATED WITH CEFPODOXIME. HE DID NOT HAVE HIS USUAL SYMPTOMS OF A UTI SUCH AS URGENCY, FREQUENCY AND "JUST NOT FEELING RIGHT". THEN ON MARCH 4RTH HE HAD A FOLLOW UP VISIT WITH GP FROM HIS ER VISIT AND HE SUSPECTED HE HAD A UTI AS HE WAS SYMPTOMATIC OF HIS USUAL UTI SYMPTOMS. HE SAID HIS AZO HOME TEST STRIP WAS POSITIVE FOR UTI AND AT THE DOCTOR THEY DID URINE TESTING WHICH WAS SUSPECT FOR UTI AND WAS PLACED ON MACROBID. HE SAID THE URINE CULTURE RESULTED IN LESS THAN 10K COLONY FORMING UNITS AND NO FURTHER TESTING WAS DONE. HE SAID WITH THE MACROBID HE WAS SYMPTOM FREE FOR 2 WEEKS AND THEN THIS PAST WEEKEND FELT LIKE HIS UTI SYMPTOMS CAME BACK SO HE WENT TO URGENT CARE AND HE WAS TOLD BASED ON THE UA HE HAD A UTI AND THE URINE CULTURE IS PENDING. HE WAS GIVEN AMOXICILLIN WHICH HE STARTED SUNDAY. HE HAD A FEVER OF 103F SUNDAY

  Patient problems: Urinary Tract Infection

  MAUDE report 24753194 ↗
• MalfunctionMar 31, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTED NOTCH ON FUNNEL AND COUDE TIP NOT ALIGNED. HE STATED EVERY ONE HE USED WAS OFF BY VARYING ANGLES AND JUST NOT ALIGNED. HE DID MENTION AS AN EXAMPLE IF ONE IS MISALIGNED BY 35 DEGREES AND HE HAS TO ANGLE THE CATHETER DIFFERENTLY SO HE CAN USE THEM COMFORTABLY SO AS TO AVOID BLEEDING. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747581 ↗
• MalfunctionMar 18, 2026Device Misassembled During Manufacturing /Shipping

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24631684 ↗
• MalfunctionMar 18, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS IN THE CURRENT MARKET UNIT HE HAS ALREADY FOUND QTY 2 MISALIGNED IS LOT 5A00617. HE "CATHS 5 X A DAY FOR RETENTION FROM BPH. HE STATES THE COUDE TIP AND THE NOTCH ON THE FUNNEL END ARE NOT PERFECTLY ALIGNED ON ALL CATHETERS. HE SAID THIS IS MISALIGNED BY VARYING DEGREES, MENTIONING SOME ARE OFF BY 20 DEGREES SOMETIMES 90 DEGREES OR SOMETIMES EVEN MORE THAN 90 DEGREES. HE SAID 60-70% OF THEM ARE ALL ALIGNED WELL IN ALL HIS ORDERS BUT THE REST ARE NOT. HE SAID WHEN HE FIRST STARTED CIC AND USING THIS PRODUCT, AGAIN ABOUT 3-4 YRS AGO, HE DID NOT REALIZE THIS MISALIGNMENT ISSUE AND SAID HE REMEMBERS IT WAS PAINFUL AND UNCOMFORTABLE WITH INSERTION OF ONE AND FELT LIKE THERE WAS A SHARPNESS WHEN HE WAS INSERTING AND DID SAY HE DID EXPERIENCE A "LITTLE BIT OF BLEEDING" WHICH RESOLVED SHORTLY. HE THEN SAW IT WAS DUE TO THE MISALIGNMENT. HE KNOWS TO KEEP THE COUDE TIP UP WHEN INSERTING AND AT THE TIME, HE WAS RELAYING ON THE NOTCH. HE SAID HE LEARNED REALLY QUICK TO NOT RELY ON THE NOTCH ON THE FUNNEL AND JUST TAKES ACCOUNT THE MISALIGNMENT TO KEEP THE COUDE TIP ITSELF POINTING UPWARDS WITH INSERTION AND THEN THEY WORK FINE FOR HIM." THIS EMDR COVERS THE UNKNOWN LOT NUMBER

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24625927 ↗
• MalfunctionMar 18, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS IN THE CURRENT MARKET UNIT HE HAS ALREADY FOUND QTY 2 MISALIGNED IS LOT 5A00617. HE "CATHS 5 X A DAY FOR RETENTION FROM BPH. HE STATES THE COUDE TIP AND THE NOTCH ON THE FUNNEL END ARE NOT PERFECTLY ALIGNED ON ALL CATHETERS. HE SAID THIS IS MISALIGNED BY VARYING DEGREES, MENTIONING SOME ARE OFF BY 20 DEGREES SOMETIMES 90 DEGREES OR SOMETIMES EVEN MORE THAN 90 DEGREES. HE SAID 60-70% OF THEM ARE ALL ALIGNED WELL IN ALL HIS ORDERS BUT THE REST ARE NOT. HE SAID WHEN HE FIRST STARTED CIC AND USING THIS PRODUCT, AGAIN ABOUT 3-4 YRS AGO, HE DID NOT REALIZE THIS MISALIGNMENT ISSUE AND SAID HE REMEMBERS IT WAS PAINFUL AND UNCOMFORTABLE WITH INSERTION OF ONE AND FELT LIKE THERE WAS A SHARPNESS WHEN HE WAS INSERTING AND DID SAY HE DID EXPERIENCE A "LITTLE BIT OF BLEEDING" WHICH RESOLVED SHORTLY. HE THEN SAW IT WAS DUE TO THE MISALIGNMENT. HE KNOWS TO KEEP THE COUDE TIP UP WHEN INSERTING AND AT THE TIME, HE WAS RELAYING ON THE NOTCH. HE SAID HE LEARNED REALLY QUICK TO NOT RELY ON THE NOTCH ON THE FUNNEL AND JUST TAKES ACCOUNT THE MISALIGNMENT TO KEEP THE COUDE TIP ITSELF POINTING UPWARDS WITH INSERTION AND THEN THEY WORK FINE FOR HIM."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24625921 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469722 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS COUDE TIP AND NOTCH ON FUNNEL NOT ALIGNED AND CAUSED BLEEDING WITH USE. HE STATES HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND THIS CATHETER WORKED WELL FOR HIM PREVIOUSLY. HE STATES HE GOT ONE BOX WHERE EVERY CATHETER HE USED HAD THIS DEFECT, HAVING USED 21 OR 22 OF THEM. HE DISCARDED 8 OR 9 OF THEM FROM THIS BOX WITHOUT USING OR CHECKING THEM FOR THIS DEFECT FROM THIS BOX. HE REPORTS THE COUDE TIP AND THE NOTCH ON FUNNEL WERE ALL OFF, MISALIGNED BY ABOUT 90 DEGREES. DUE TO THIS MISALIGNMENT, HE EXPERIENCED SOME BLEEDING WITH THE FIRST ONE USED. THE BLEEDING STOPPED QUICKLY WITHOUT INTERVENTION, AND IT WAS CAUSED BECAUSE IT WAS VERY DIFFICULT TO PUT IN DUE TO THIS ISSUE AND HE DIDN'T REALIZE THE MISALIGNMENT WITH FIRST ONE USED WITH THE DEFECT. HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND NEVER HAD THIS HAPPEN BEFORE. ONCE THE CATHETER WAS REMOVED, HE COULD SEE THE MISALIGNMENT. FROM THE NOTCH ON THE FUNNEL THE COUDE TIPS APPEAR TO BE POINTING 90 DEGREES TO THE LEFT. NO PHOTO AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469641 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469640 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS COUDE TIP AND NOTCH ON FUNNEL NOT ALIGNED AND CAUSED BLEEDING WITH USE. HE STATES HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND THIS CATHETER WORKED WELL FOR HIM PREVIOUSLY. HE STATES HE GOT ONE BOX WHERE EVERY CATHETER HE USED HAD THIS DEFECT, HAVING USED 21 OR 22 OF THEM. HE DISCARDED 8 OR 9 OF THEM FROM THIS BOX WITHOUT USING OR CHECKING THEM FOR THIS DEFECT FROM THIS BOX. HE REPORTS THE COUDE TIP AND THE NOTCH ON FUNNEL WERE ALL OFF, MISALIGNED BY ABOUT 90 DEGREES. DUE TO THIS MISALIGNMENT, HE EXPERIENCED SOME BLEEDING WITH THE FIRST ONE USED. THE BLEEDING STOPPED QUICKLY WITHOUT INTERVENTION, AND IT WAS CAUSED BECAUSE IT WAS VERY DIFFICULT TO PUT IN DUE TO THIS ISSUE AND HE DIDN'T REALIZE THE MISALIGNMENT WITH FIRST ONE USED WITH THE DEFECT. HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND NEVER HAD THIS HAPPEN BEFORE. ONCE THE CATHETER WAS REMOVED, HE COULD SEE THE MISALIGNMENT. FROM THE NOTCH ON THE FUNNEL THE COUDE TIPS APPEAR TO BE POINTING 90 DEGREES TO THE LEFT. NO PHOTO AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469639 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469638 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS COUDE TIP AND NOTCH ON FUNNEL NOT ALIGNED AND CAUSED BLEEDING WITH USE. HE STATES HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND THIS CATHETER WORKED WELL FOR HIM PREVIOUSLY. HE STATES HE GOT ONE BOX WHERE EVERY CATHETER HE USED HAD THIS DEFECT, HAVING USED 21 OR 22 OF THEM. HE DISCARDED 8 OR 9 OF THEM FROM THIS BOX WITHOUT USING OR CHECKING THEM FOR THIS DEFECT FROM THIS BOX. HE REPORTS THE COUDE TIP AND THE NOTCH ON FUNNEL WERE ALL OFF, MISALIGNED BY ABOUT 90 DEGREES. DUE TO THIS MISALIGNMENT, HE EXPERIENCED SOME BLEEDING WITH THE FIRST ONE USED. THE BLEEDING STOPPED QUICKLY WITHOUT INTERVENTION, AND IT WAS CAUSED BECAUSE IT WAS VERY DIFFICULT TO PUT IN DUE TO THIS ISSUE AND HE DIDN'T REALIZE THE MISALIGNMENT WITH FIRST ONE USED WITH THE DEFECT. HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND NEVER HAD THIS HAPPEN BEFORE. ONCE THE CATHETER WAS REMOVED, HE COULD SEE THE MISALIGNMENT. FROM THE NOTCH ON THE FUNNEL THE COUDE TIPS APPEAR TO BE POINTING 90 DEGREES TO THE LEFT. NO PHOTO AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469614 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469610 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS COUDE TIP AND NOTCH ON FUNNEL NOT ALIGNED AND CAUSED BLEEDING WITH USE. HE STATES HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND THIS CATHETER WORKED WELL FOR HIM PREVIOUSLY. HE STATES HE GOT ONE BOX WHERE EVERY CATHETER HE USED HAD THIS DEFECT, HAVING USED 21 OR 22 OF THEM. HE DISCARDED 8 OR 9 OF THEM FROM THIS BOX WITHOUT USING OR CHECKING THEM FOR THIS DEFECT FROM THIS BOX. HE REPORTS THE COUDE TIP AND THE NOTCH ON FUNNEL WERE ALL OFF, MISALIGNED BY ABOUT 90 DEGREES. DUE TO THIS MISALIGNMENT, HE EXPERIENCED SOME BLEEDING WITH THE FIRST ONE USED. THE BLEEDING STOPPED QUICKLY WITHOUT INTERVENTION, AND IT WAS CAUSED BECAUSE IT WAS VERY DIFFICULT TO PUT IN DUE TO THIS ISSUE AND HE DIDN'T REALIZE THE MISALIGNMENT WITH FIRST ONE USED WITH THE DEFECT. HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND NEVER HAD THIS HAPPEN BEFORE. ONCE THE CATHETER WAS REMOVED, HE COULD SEE THE MISALIGNMENT. FROM THE NOTCH ON THE FUNNEL THE COUDE TIPS APPEAR TO BE POINTING 90 DEGREES TO THE LEFT. NO PHOTO AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469498 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS COUDE TIP AND NOTCH ON FUNNEL NOT ALIGNED AND CAUSED BLEEDING WITH USE. HE STATES HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND THIS CATHETER WORKED WELL FOR HIM PREVIOUSLY. HE STATES HE GOT ONE BOX WHERE EVERY CATHETER HE USED HAD THIS DEFECT, HAVING USED 21 OR 22 OF THEM. HE DISCARDED 8 OR 9 OF THEM FROM THIS BOX WITHOUT USING OR CHECKING THEM FOR THIS DEFECT FROM THIS BOX. HE REPORTS THE COUDE TIP AND THE NOTCH ON FUNNEL WERE ALL OFF, MISALIGNED BY ABOUT 90 DEGREES. DUE TO THIS MISALIGNMENT, HE EXPERIENCED SOME BLEEDING WITH THE FIRST ONE USED. THE BLEEDING STOPPED QUICKLY WITHOUT INTERVENTION, AND IT WAS CAUSED BECAUSE IT WAS VERY DIFFICULT TO PUT IN DUE TO THIS ISSUE AND HE DIDN'T REALIZE THE MISALIGNMENT WITH FIRST ONE USED WITH THE DEFECT. HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND NEVER HAD THIS HAPPEN BEFORE. ONCE THE CATHETER WAS REMOVED, HE COULD SEE THE MISALIGNMENT. FROM THE NOTCH ON THE FUNNEL THE COUDE TIPS APPEAR TO BE POINTING 90 DEGREES TO THE LEFT. NO PHOTO AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469496 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS COUDE TIP AND NOTCH ON FUNNEL NOT ALIGNED AND CAUSED BLEEDING WITH USE. HE STATES HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND THIS CATHETER WORKED WELL FOR HIM PREVIOUSLY. HE STATES HE GOT ONE BOX WHERE EVERY CATHETER HE USED HAD THIS DEFECT, HAVING USED 21 OR 22 OF THEM. HE DISCARDED 8 OR 9 OF THEM FROM THIS BOX WITHOUT USING OR CHECKING THEM FOR THIS DEFECT FROM THIS BOX. HE REPORTS THE COUDE TIP AND THE NOTCH ON FUNNEL WERE ALL OFF, MISALIGNED BY ABOUT 90 DEGREES. DUE TO THIS MISALIGNMENT, HE EXPERIENCED SOME BLEEDING WITH THE FIRST ONE USED. THE BLEEDING STOPPED QUICKLY WITHOUT INTERVENTION, AND IT WAS CAUSED BECAUSE IT WAS VERY DIFFICULT TO PUT IN DUE TO THIS ISSUE AND HE DIDN'T REALIZE THE MISALIGNMENT WITH FIRST ONE USED WITH THE DEFECT. HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND NEVER HAD THIS HAPPEN BEFORE. ONCE THE CATHETER WAS REMOVED, HE COULD SEE THE MISALIGNMENT. FROM THE NOTCH ON THE FUNNEL THE COUDE TIPS APPEAR TO BE POINTING 90 DEGREES TO THE LEFT. NO PHOTO AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469495 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS COUDE TIP AND NOTCH ON FUNNEL NOT ALIGNED AND CAUSED BLEEDING WITH USE. HE STATES HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND THIS CATHETER WORKED WELL FOR HIM PREVIOUSLY. HE STATES HE GOT ONE BOX WHERE EVERY CATHETER HE USED HAD THIS DEFECT, HAVING USED 21 OR 22 OF THEM. HE DISCARDED 8 OR 9 OF THEM FROM THIS BOX WITHOUT USING OR CHECKING THEM FOR THIS DEFECT FROM THIS BOX. HE REPORTS THE COUDE TIP AND THE NOTCH ON FUNNEL WERE ALL OFF, MISALIGNED BY ABOUT 90 DEGREES. DUE TO THIS MISALIGNMENT, HE EXPERIENCED SOME BLEEDING WITH THE FIRST ONE USED. THE BLEEDING STOPPED QUICKLY WITHOUT INTERVENTION, AND IT WAS CAUSED BECAUSE IT WAS VERY DIFFICULT TO PUT IN DUE TO THIS ISSUE AND HE DIDN'T REALIZE THE MISALIGNMENT WITH FIRST ONE USED WITH THE DEFECT. HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND NEVER HAD THIS HAPPEN BEFORE. ONCE THE CATHETER WAS REMOVED, HE COULD SEE THE MISALIGNMENT. FROM THE NOTCH ON THE FUNNEL THE COUDE TIPS APPEAR TO BE POINTING 90 DEGREES TO THE LEFT. NO PHOTO AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469494 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469491 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469488 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469415 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS COUDE TIP AND NOTCH ON FUNNEL NOT ALIGNED AND CAUSED BLEEDING WITH USE. HE STATES HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND THIS CATHETER WORKED WELL FOR HIM PREVIOUSLY. HE STATES HE GOT ONE BOX WHERE EVERY CATHETER HE USED HAD THIS DEFECT, HAVING USED 21 OR 22 OF THEM. HE DISCARDED 8 OR 9 OF THEM FROM THIS BOX WITHOUT USING OR CHECKING THEM FOR THIS DEFECT FROM THIS BOX. HE REPORTS THE COUDE TIP AND THE NOTCH ON FUNNEL WERE ALL OFF, MISALIGNED BY ABOUT 90 DEGREES. DUE TO THIS MISALIGNMENT, HE EXPERIENCED SOME BLEEDING WITH THE FIRST ONE USED. THE BLEEDING STOPPED QUICKLY WITHOUT INTERVENTION, AND IT WAS CAUSED BECAUSE IT WAS VERY DIFFICULT TO PUT IN DUE TO THIS ISSUE AND HE DIDN'T REALIZE THE MISALIGNMENT WITH FIRST ONE USED WITH THE DEFECT. HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND NEVER HAD THIS HAPPEN BEFORE. ONCE THE CATHETER WAS REMOVED, HE COULD SEE THE MISALIGNMENT. FROM THE NOTCH ON THE FUNNEL THE COUDE TIPS APPEAR TO BE POINTING 90 DEGREES TO THE LEFT. NO PHOTO AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469407 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS COUDE TIP AND NOTCH ON FUNNEL NOT ALIGNED AND CAUSED BLEEDING WITH USE. HE STATES HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND THIS CATHETER WORKED WELL FOR HIM PREVIOUSLY. HE STATES HE GOT ONE BOX WHERE EVERY CATHETER HE USED HAD THIS DEFECT, HAVING USED 21 OR 22 OF THEM. HE DISCARDED 8 OR 9 OF THEM FROM THIS BOX WITHOUT USING OR CHECKING THEM FOR THIS DEFECT FROM THIS BOX. HE REPORTS THE COUDE TIP AND THE NOTCH ON FUNNEL WERE ALL OFF, MISALIGNED BY ABOUT 90 DEGREES. DUE TO THIS MISALIGNMENT, HE EXPERIENCED SOME BLEEDING WITH THE FIRST ONE USED. THE BLEEDING STOPPED QUICKLY WITHOUT INTERVENTION, AND IT WAS CAUSED BECAUSE IT WAS VERY DIFFICULT TO PUT IN DUE TO THIS ISSUE AND HE DIDN'T REALIZE THE MISALIGNMENT WITH FIRST ONE USED WITH THE DEFECT. HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND NEVER HAD THIS HAPPEN BEFORE. ONCE THE CATHETER WAS REMOVED, HE COULD SEE THE MISALIGNMENT. FROM THE NOTCH ON THE FUNNEL THE COUDE TIPS APPEAR TO BE POINTING 90 DEGREES TO THE LEFT. NO PHOTO AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469397 ↗
• MalfunctionFeb 27, 2026Device Misassembled During Manufacturing /Shipping

  END USER REPORTS COUDE TIP AND NOTCH ON FUNNEL NOT ALIGNED AND CAUSED BLEEDING WITH USE. HE STATES HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND THIS CATHETER WORKED WELL FOR HIM PREVIOUSLY. HE STATES HE GOT ONE BOX WHERE EVERY CATHETER HE USED HAD THIS DEFECT, HAVING USED 21 OR 22 OF THEM. HE DISCARDED 8 OR 9 OF THEM FROM THIS BOX WITHOUT USING OR CHECKING THEM FOR THIS DEFECT FROM THIS BOX. HE REPORTS THE COUDE TIP AND THE NOTCH ON FUNNEL WERE ALL OFF, MISALIGNED BY ABOUT 90 DEGREES. DUE TO THIS MISALIGNMENT, HE EXPERIENCED SOME BLEEDING WITH THE FIRST ONE USED. THE BLEEDING STOPPED QUICKLY WITHOUT INTERVENTION, AND IT WAS CAUSED BECAUSE IT WAS VERY DIFFICULT TO PUT IN DUE TO THIS ISSUE AND HE DIDN'T REALIZE THE MISALIGNMENT WITH FIRST ONE USED WITH THE DEFECT. HE HAS BEEN USING THIS PRODUCT FOR MANY YEARS AND NEVER HAD THIS HAPPEN BEFORE. ONCE THE CATHETER WAS REMOVED, HE COULD SEE THE MISALIGNMENT. FROM THE NOTCH ON THE FUNNEL THE COUDE TIPS APPEAR TO BE POINTING 90 DEGREES TO THE LEFT. NO PHOTO AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24469394 ↗