Self-CathRecalls & reported problems across all models
Coloplast A/S · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 14 models of Self-Cath by Coloplast A/S in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2015 and Aug 11, 2022 — classified as 17 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Self-Cath problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Device Operates Differently Than Expected3
- Break2
- Difficult to Remove2
- Material Integrity Problem2
- No Device Output2
- Bent1
- Component Missing1
Patient problems
- Hemorrhage/Blood Loss/Bleeding6
- No Known Impact Or Consequence To Patient5
- Injury3
- Urinary Tract Infection3
- Hematuria2
- Laceration(s)2
- Pain2
- Tissue Breakdown2
Self-Cath models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Self-Cath 50453 / 414CATHETER, STRAIGHT3 reports
- Self-Cath 50452 / 412CATHETER, STRAIGHT3 reports
- Self-Cath 50196 / 240CATHETER, STRAIGHT2 reports
- Self-Cath 50455 / 418CATHETER, STRAIGHT2 reports
- Self-Cath 50468 / 614CATHETER, STRAIGHT2 reports
- Self-Cath 50183 / 116CATHETER, STRAIGHT1 report
- Self-Cath 50441 / 306CATHETER, STRAIGHT1 report
- Self-Cath 50220 / 460CATHETER, STRAIGHT1 report
- Self-Cath 50476 / 818CATHETER, STRAIGHT1 report
- Self-Cath 50454 / 416CATHETER, STRAIGHT1 report
- Self-Cath 50474 / 814CATHETER, STRAIGHT1 report
- Self-Cath 50443 / 310CATHETER, STRAIGHT1 report
- Self-Cath 50463 / 214CATHETER, STRAIGHT1 report
- Self-Cath 50462 / 212CATHETER, STRAIGHT1 report
Recent Self-Cath adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 11, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE AVAILABLE INFORMATION, THIS CASE INVOLVES A FEMALE PATIENT WHO STATES PRIOR TO HER LAST ORDER OF COLOPLAST CATHETERS, SHE JUST HAD A UTI AND IS CONVINCED THAT IT WAS FROM COLOPLAST CATHETERS. THE UTI PLACED HER IN HOSPITAL, BUT IT WAS NOT REPORTED IF INTERVENTION WAS REQUIRED OR WHAT KIND OF TREATMENT WAS RECEIVED. SHE HAS BEEN ADVISED THAT THERE COULD BE MANY VARIOUS REASONS FOR THE DEVELOPMENT OF UTI'S AND THAT SHE SHOULD BE SPEAKING TO HER DOCTOR FOR TREATMENT PLANS OR DIFFERENT MEDICATIONS THAT SHE COULD POTENTIALLY TAKE TO HELP PREVENT THEM. ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER, BUT NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Patient problems: Urinary Tract Infection
MAUDE report 15209202 ↗InjuryJun 20, 2022Difficult to Remove; Difficult to Remove
ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT DESCRIBES AN EVENT WHERE AN END-USER (FEMALE) OF UNKNOWN AGE WAS HARMED. THE COMPLAINT IS FILED BY THE END-USER¿S FAMILY, AS THE END-USER HERSELF IS A MINOR. THE EVENT IS DESCRIBED AS THE CATHETER BREAKING AND LEAVING THE TIP INSIDE THE END-USER¿S BODY AND TWO SURGERIES WERE NEEDED TO REMOVE THE TIP. THE END-USER WAS FINALLY DISCHARGED THE 2ND OF JUNE. THE FIRST SURGERY REQUIRED 1 OVERNIGHT STAY AT THE HOSPITAL, AND THE SECOND A 2-NIGHT STAY. IT IS UNCLEAR WHAT TYPE OF SURGERY WAS PERFORMED, WHY THE SECOND ONE WAS NEEDED, AND WHAT HARM WAS CAUSED. THE REASON FOR THE CATHETER BREAKING IS NOT KNOWN, THERE ARE NO INDICATIONS OF THE PRODUCT BEING FAULTY, AND IT IS UNKNOWN WHETHER THE PRODUCT WAS USED ACCORDING TO THE INSTRUCTION FOR USE. THE REASON FOR NEEDING INTERMITTENT CATHETERISATION AND THE FAMILY¿S EXPERIENCE WITH INTERMITTENT CATHETERS IS NOT STATED. ALSO, THE REASON FOR THE FEMALE END-USER USING A MALE-CATHETERS IS NOT CLEAR. CHILD PROTECTIVE SERVICE IS STATED TO BE INVOLVED, BUT NOT FOR WHAT REASON. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Tissue Breakdown
MAUDE report 14744221 ↗InjuryMar 1, 2022Sharp Edges; Sharp Edges
ACCORDING TO THE INFORMATION AVAILABLE, THIS COMPLAINT CONCERNS A MALE END USER WHO HAD BEEN CATHETERIZING FOR ALMOST 3-4 YEARS WITH THE SELF-CATH SOFT CATHETER PRIOR TO THE INCIDENT. THE END USER STATED THAT HE WOULD USUALLY EXPERIENCE MINOR BLEEDING WHEN CATHETERIZING BUT HAD A DIFFERENT EXPERIENCE UPON THE INCIDENT REPORTED. THE END USER FELT PAIN DURING INSERTION OF THE CATHETER, WHICH HE TRIED TO EASE BY APPLYING MORE LUBRICANT. IT DID NOT HELP, AND THE END USER REPORTED BLEEDING TO THE POINT THAT BLOOD WENT INTO THE CATHETER TUBE CAUSING THE FLOW OF URINE TO STOP. HE WAS NOT ABLE TO INSERT THE CATHETER TO REACH THE BLADDER BECAUSE OF PAIN IN THE URETHRA. THE END USER WAS ADMITTED TO A HOSPITAL FOR URINE RETENTION THE END USER HAD LATER CONFIRMED THAT HE HAD NO SYMPTOMS FROM THE BLEEDING AND DID RECOVER FROM IT AND WAS ADMITTED IN THE HOSPITAL FOR 4 DAYS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Dysuria; Hematuria; Urinary Retention
MAUDE report 13637952 ↗InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem
THIS CASE INVOLVES A MALE END USER (EU) WHO HAS BEEN CATHETERIZING FOR YEARS. OVER THE LAST 5 OR SO MONTHS HIS PROSTATE HAS ENLARGED AND HE HAS NOTICED BLEEDING DURING CATHETERIZATION. THIS BLEEDING STARTED OUT AS MAYBE A 1/2 INCH SMEAR OF BLOOD ON HIS CATHETER TO NOW QUITE A BIT MORE. EVENTUALLY THE BLOOD WAS OBSERVED IN HIS BLADDER FOR WHICH HE UNDERWENT AN ABLATION SURGICAL PROCEDURE TO HELP EASE THE CATHETERIZATION PROCESS. THE EU WAS DISCHARGED ON (B)(6) 2021 AND CURRENTLY HAS A FOLEY CATHETER IN. HIS DOCTOR HAS RECOMMENDED THE USE OF SOFTER CATHETERS WITH A COUDE TIP FOR FUTURE CATHETERIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hematuria; Perforation of Vessels
MAUDE report 12009635 ↗InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, A FEMALE END-USER INFORMS THAT DURING THE LAST YEAR SHE HAS HAD 10 URINARY TRACT INFECTIONS (UTIS) AND 19 HOSPITAL STAYS DUE TO CATHETERISING. DURING THE LAST 30 YEARS SHE HAS HAD RECURRENT UTIS AND HOSPITALIZATION. THE END-USES STATES THAT IT IS NOT A PROBLEM WITH THE CATHETERS, THEY ARE NOT DEFECTIVE. THE END-USER ALSO INFORMS THAT SHE HAS BEEN HOSPITALIZED OVERNIGHT MANY TIMES OVER THE YEARS OF CATHETERIZING AND SHE HAS SEEN MANY DOCTORS ABOUT HOW TO STOP THE UTI'S FROM HAPPENING, BUT NO SOLUTION HAS BEEN FOUND YET. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Urinary Tract Infection
MAUDE report 11802686 ↗InjuryMar 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS CASE INVOLVES A MALE PATIENT WHO STATED THAT HE RECENTLY HAD A SEVERE URINARY TRACT INFECTION (UTI) THAT REQUIRED HIM TO GO TO THE HOSPITAL. THE END-USER HAD EXPERIENCED UTIS BEFORE AND WAS FAMILIAR WITH USING INTERMITTENT CATHETERS. THE END-USER DID SEEK MEDICAL ATTENTION FOR THE UTI, BUT IT IS UNCLEAR WHETHER IT WAS HIS OWN DOCTOR, EMERGENCY ROOM OR ADMISSION TO THE HOSPITAL. NO INFORMATION ABOUT TREATMENT OR MEDICATION COULD BE OBTAINED. THE END-USER HAS FULLY RECOVERED WITH NO LASTING DAMAGE OR ISSUES. THE END-USER STATES THAT THERE WAS NOTHING WRONG WITH THE CATHETERS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Urinary Tract Infection
MAUDE report 11426654 ↗InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS CASE INVOLVES A (B)(6) FEMALE END USER. ON (B)(6) 2020 AT ABOUT 10 P.M. SHE WENT TO THE REST ROOM TO PERFORM CATHETERIZATION AND IMMEDIATELY FELT PAIN AFTER TAKING CATHETER OUT. ABOUT 1 HOUR LATER SHE WENT TO THE EMERGENCY ROOM WHERE SHE WAS DIAGNOSED WITH POSSIBLE GALL BLADDER ISSUES. SHE WAS ADMITTED TO THE HOSPITAL FOR A SURGICAL PROCEDURE. WHEN THE SURGERY WAS COMPLETED SHE WAS INFORMED THAT HER GALL BLADDER WAS FINE, THAT WHEN THEY MOVED THE GALL BLADDER TO SEE IF THERE WERE GALL STONES PRESENT IT WAS OBSERVED THAT HER BLADDER WAS PERFORATED. THE PERFORATION WAS TREATED AND THE PATIENT WAS PLACED ON A FOLEY CATHETER UNTIL (B)(6) 2020 WHEN IT WAS REMOVED. THE PHYSICIAN BELIEVED THE CAUSE OF THE BLADDER PERFORATION WAS CATHETERIZATION. THE PATIENT IS WELL WITH NO FURTHER ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Pain; Perforation
MAUDE report 11349632 ↗InjurySep 26, 2018Break
ACCORDING TO THE AVAILABLE INFORMATION, THE SELF-CATH TIP BROKE. THE PATIENT IS KEEPING THE CATH INSERTED OVERNIGHT AND THEN IRRIGATING WITH IT IN THE MORNING. THE ¾ INCHES OF THE CATHETER TIP FELL OFF/ BROKE INSIDE THE USER. SURGERY IS SCHEDULED TO REMOVE FROM BLADDER.
Patient problems: No Code Available
MAUDE report 7910727 ↗InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT COMPLAINT REGARDING ITEM# 614 - LOT# 5607497 AND 5865261. THE PATIENT STATED THAT THE CATHETERS ARE CAUSING HIM TO BLEED. THE PATIENT STATED THAT HOSPITALIZATION WAS REQUIRED. THE CATHETERS MAY HAVE BEEN NICKING A BLOOD VESSEL IN THE PROSTATE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 7285652 ↗InjuryFeb 20, 2018Positioning Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT COMPLAINED REGARDING ITEM# (B)(4)- LOT# 5607497 AND 5865261. THE PATIENT STATED THAT THE CATHETERS ARE CAUSING HIM TO BLEED. THE PATIENT STATED THAT HOSPITALIZATION WAS REQUIRED. THE CATHETERS MAY HAVE BEEN NICKING A BLOOD VESSEL IN THE PROSTATE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 7284235 ↗InjuryOct 11, 2017Device Operates Differently Than Expected
ACCORDING TOT HE AVAILABLE INFORMATION, PATIENT IS STATING THAT THE CATHETER WAS BUNCHING UP IN HIS URETHRA. PATIENT WENT TO THE HOSPITAL AND THEY PUT HIM IN A PERMANENT CATHETER. PATIENT ALSO STATED THAT HE HAS TRAUMA TO URETHRA AND A LOT OF BLEEDING. END USER ALSO SAID THAT WHEN HE WAS HAVING A BOWEL MOVEMENT EARLIER TODAY AND WHEN HE STRAINED BLOOD CAME OUT OF THE CATHETER. HE SAID HE BLED FOR 45 MINUTES. EU STATED THAT THE DOCTOR SAID THAT THE INSIDE TRACK HAS BEEN TORN BADLY. NO UTI.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury
MAUDE report 6941872 ↗InjuryJan 31, 2017Difficult to Remove; Device Handling Problem
WAS THE USER HOSPITALIZED FOR MORE THAN 24 HRS/OVERNIGHT ADMISSION TO GET THE CATHETER SURGICALLY REMOVED? YES, SHE WAS IN THE HOSPITAL FOR ABOUT A DAY. BESIDES HAVING THE CATHETER STUCK WAS THE USER HARMED IN ANY WAY? PAIN, BLEEDING ETC.? SHE COULDN'T URINATE WHILE THE CATHETER WAS STUCK. WHAT WAS THE INDICATION FOR USE? NO SPECIFIC REASON TO USE 240, DIDN'T RECEIVE INSTRUCTION FROM HER PHYSICIAN, BUT RECEIVED A LITTLE INSTRUCTION. IS THE IT A FIRST TIME USER? SHE HAS BEEN CATHING FOR 15 YEARS, BUT HAS BEEN USING THE 240 FOR ABOUT A YEAR BUT HAS USED 214 PREVIOUSLY. WHAT IS THE OUTCOME? WAS IN THE HOSPITAL FOR A DAY AFTER HER SURGERY, THEN HAD A FOLEY CATHETER FOR ABOUT TWO WEEKS, AND WENT BACK TO INTERMITTENT CATHETERS. *EU IS A PARAPLEGIC.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6291042 ↗InjuryAug 11, 2016Bent; Crack
ACCORDING TO THE AVAILABLE INFORMATION, END-USER HAD A DAMAGED PRODUCT. END-USER DOES NOT THINK THAT ANY OF THE CATHETER REMAINS IN HIM. APPEARANCE OF A CRACK IN THE CATHETER NEAR THE BEND AND A BARB LIKE PROJECTION MAKING THE WITHDRAWAL PAINFUL. THE BLEEDING HAS SUBSIDED AND HAS A DOCTOR'S APPOINTMENT NEXT MONTH. ADVISED TO SEEK MEDICAL ATTENTION IMMEDIATELY IF ANY FURTHER ISSUES ARISE AND HE HAS AGREED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 5870179 ↗MalfunctionJul 6, 2016Break
ACCORDING TO THE AVAILABLE INFORMATION, CUSTOMER STATED THAT THE CATHETER WAS DIFFICULT TO INSERT AND SHE NOTICED THAT THE TIP WAS BROKEN OFF. SHE USED A CATHETER AND WENT TO REUSE IT A FEW HOURS LATER. IT WOULDN'T GO IN PROPERLY. SHE LOOKED AT IT AND REALIZED THE SMOOTH END HAD BROKEN OFF. SHE DOES NOT THINK IT BROKE WHILE CATHING. END USER STATED THAT THERE WAS NO DISCOMFORT AT THE TIME OF THE INITIAL CATHETERIZATION EPISODE. SHE STATED THAT SHE FOUND IT DIFFICULT TO INSERT THE CATHETER AFTER CLEANING IT FOR REUSE AND THAT WAS WHEN SHE DISCOVERED THE MISSING TIP. IT DID NOT APPEAR TO BE NOTICED DURING THE CLEANING PROCESS. THERE WAS NO PHYSICAL HARM OR INJURY. SHE DID CONSULT WITH HER PHYSICIAN AND WAS GIVEN A RENAL ULTRASOUND TO INVESTIGATE IF THE MISSING TIP WAS IN THE URINARY TRACT. THE RESULTS OF THE ULTRASOUND WERE NEGATIVE. THERE IS NO PORTION OF THE CATHETER INSIDE HER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5773466 ↗InjuryMay 24, 2016Device Operates Differently Than Expected
ACCORDING TO THE AVAILABLE INCIDENT INFORMATION STATES ITEM 818 IS CUTTING END-USER'S PENIS. CURRENTLY THERE IS NO OTHER INFORMATION ON THE INJURY.
Patient problems: Injury; Laceration(s)
MAUDE report 5676890 ↗
Other Coloplast A/S products
All Coloplast A/S devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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