SpeediCath Standard 28414Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05708932020275), received between Jan 31, 2017 and May 21, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2024Sharp Edges; Sharp Edges

  ACCORDING TO THE AVAILABLE INFORMATION, A MALE END-USER WAS HOSPITALIZED DUE TO AN INCIDENT WITH A SPEEDICATH STANDARD MALE URINARY CATHETER. THE INCIDENT WAS DESCRIBED TO BE A PUNCTURED PROSTATE, WHICH CAUSED A BLOOD VESSEL TO BURST. THE END-USER EXPERIENCED BLEEDING, AND DIZZINESS AND WAS TREATED UNDER ANAESTHESIA TO CLEAR UP BLOOD AND DEBRIS. HE WAS HOSPITALIZED FOR 3 DAYS AND WERE DISCHARGED WITH AN INDWELLING CATHETER FOR 10-14 DAYS AS WELL AS ANTIBIOTICS, VITAMINS AND IRON PILLS. THE END-USER IS AN EXPERIENCE CATHETER USER AND HAVE USED INTERMITTENT CATHETERS FOR 4 YEARS AND HAS NOT CHANGED HIS INSERTION ROUTINE. HE HAS BENIGN PROSTATIC HYPERPLASIA (BPH) BUT STATED THAT WHEN INSERTING THE CATHETER BEFORE THE INCIDENT HE DID NOT FEEL ANY RESISTANCE AT ALL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Urethral Stenosis/Stricture

  MAUDE report 19361090 ↗
• InjuryMar 4, 2024Partial Blockage; Partial Blockage

  ACCORDING TO THE AVAILABLE INFORMATION, THE COMPLAINT DESCRIBED IN (B)(4) CONCERNS A PATIENT WITH BLADDER CANCER WHO EXPERIENCED A TRAUMATIC CATHETERISATION WITH SC STANDARD MALE. FOLLOWING USE OF THE SPEEDICATH CATHETER TO EMPTY THE BLADDER, THE SPEEDICATH CATHETER WAS USED FOR BCG INSTILLATION (AS A TREATMENT FOR THE BLADDER CANCER), WHICH CAUSED BCG SEPSIS AND HOSPITALIZATION OF THE PATIENT. THE RISK OF HARM IS SHORT-TERM, AND THE PATIENT IS NO LONGER HOSPITALIZED.

  Patient problems: Sepsis; Tissue Breakdown

  MAUDE report 18827347 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS A MALE END USER WHO STATED HE GOT INFECTED WITH UTI¿S USING COLOPLAST CATHETERS. THE END USER STATED HE WAS HOSPITALIZED AS A RESULT BUT DID NOT PROVIDE ANY INFORMATION IN REGARDS TO THE DATES ADMITTED, TREATMENT RECEIVED, OR LENGTH OF TIME. HE DOES NOT USE THE CATHETERS ANY LONGER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Urinary Tract Infection

  MAUDE report 16777480 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT DESCRIBES A (B)(6) -YEAR-OLD MALE END-USER WHO WAS USING SPEEDICATH STANDARD INTERMITTENT CATHETER FOR A CATHETERISATION. HE HAD USED ABOUT 15 CATHETERS, THE OTHERS WITHOUT PROBLEMS, BUT WITH THE LAST ONE HE EXPERIENCED BLEEDING, FOR WHICH HE NEEDED TREATMENT AT THE EMERGENCY ROOM. THE END-USE DESCRIBES THAT HE INSERTS THE CATHETER SLOWLY ON BOTH THE INSERTION AND ON THE WAY OUT OF THE URETHRA, BUT WHEN INSERTING THIS LAST CATHETER, HE FELT LIKE HE HAD TO PUSH THE CATHETER HARD TO GET IT INTO THE BLADDER. HE FELT PAIN AFTER A WHILE. THE AMOUNT OF BLOOD IS STATED TO BE MEASURED BY THE END-USER HIM-SELF TO ABOUT 2 LITERS. THE END-USER WAS AT THE HOSPITAL FOR ABOUT AN HOUR AND AN INDWELLING CATHETER (FOLEY CATHETER) WAS PLACED. HE WILL SEE HIS MEDICAL DOCTOR SOON AND KEEP THE INDWELLING CATHETER UNTIL FURTHER NOTICE. THE END-USER STATES THAT THIS IS THE THIRD TIME HE IS BEING PRESCRIBED INTERMITTENT URINARY CATHETERS AND THE PREVIOUS ATTEMPTS WITH INTERMITTENT CATHETER DID ALSO RESULT IN BLEEDING AND AN INDWELLING CATHETER, BUT THE BLEEDING AT THIS INCIDENT WAS WORSE THAN THE PREVIOUS EVENTS. THE END-USER STATES THAT THE CATHETERS

  Patient problems: Exsanguination

  MAUDE report 13059731 ↗
• InjuryNov 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE INFORMATION PROVIDED, THE COMPLAINT DESCRIBES HARMS CAUSED TO A (B)(6)-YEAR-OLD MALE END-USER. THE END-USER WAS USING SPEEDICATH STANDARD CATHETERS FROM A SAMPLE-PACK. WHEN CATHETERISING HE EXPERIENCED BLEEDING, WHICH WAS SEVERE ENOUGH FOR HIM TO VISIT THE EMERGENCY ROOM (ER), WHERE HE WAS ADMITTED. THE EVALUATION FROM THE ER IS STATED TO BE TRAUMA TO THE PROSTATE WHEN INSERTING THE CATHETER. THE END-USER WAS PUT ON ANTIBIOTICS, BLOOD THINNERS AND INDWELLING CATHETER. IT IS STATED THAT HE WE STAY ON THE INDWELLING CATHETER UNTIL SURGERY, AND HEREAFTER IC MIGHT NOT BE NECESSARY FOR HIM. THE END-USER WAS IN HOSPITAL FROM (B)(6) OCTOBER AND WAS RE-ADMITTED THE SAME DAY DUE TO BLEEDING STARTING AGAIN. THE END-USER HAS A SCHEDULED PROSTATE SURGERY (B)(6) OCTOBER AFTER WHICH INTERMITTENT CATHETERIZATION MAY NOT BE NEEDED. THE END-USER STATES THAT HE DID NOT NOTICE ANY SHARP EDGES OR OTHER ON THE CATHETER ITSELF. HE THINKS THAT IT IS A USE ERROR (MAYBE HE INSERTED IT TOO FORCEFUL). THE MEDICAL DOCTOR STATES THAT HE BELIEVES THAT THE BLEEDING WAS CAUSED BY THE BLOOD THINNER MEDICATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematuria; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12738984 ↗
• InjuryOct 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS CASE INVOLVES AN EXPERIENCED END USER WHO HAS USED COLOPLAST CATHETERS FOR 21 YEARS. IT IS REPORTED THAT THE LAST 8 BOXES OF CATHETERS HE RECEIVED HAVE BEEN DEFECTIVE CAUSING HIM TO DEVELOP BLEEDING, A UTI, AND HOSPITALIZATION. NO MORE INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Hematuria; Pain

  MAUDE report 12592517 ↗
• InjurySep 14, 2020Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert

  THIS CASE CONCERNS A (B)(6) MALE PATIENT WHO HAS BEEN TAKING BLOOD THINNERS (10 MG) FOR ABOUT 10 YEARS. THE END USER HAD BEEN USING THE SPEEDICATH CATHETERS FOR ABOUT 2 WEEKS OR MORE. ONE NIGHT THE CATHETER WAS UNABLE TO BE INSERTED, SO HE RE-TRIED THE NEXT DAY. THE CATHETER WAS INSERTED, BUT UPON REMOVAL BLACK BLOOD WAS OBSERVED IN THE CATHETER FIRST, THEN URINE, AND THEN MORE BLOOD. AFTER USING A DIAPER DURING THE DAY AS A PRECAUTION DUE TO THE BLEEDING HE OBSERVED THAT THE DIAPER WAS FILLED WITH BLOOD. 911 WAS CALLED IMMEDIATELY. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) AND DISCHARGED ON (B)(6). THE PATIENT WAS PLACED ON A DIARETIC CALLED FUROSEMIDE IN THE HOSPITAL AND FLUID WAS TAKEN FROM HIS STOMACH. THE PATIENT REMAINS ON THIS MEDICATION AND IS SUPPOSED TO TAKE 1 20G TABLET A DAY FOR ONE MONTH. AFTER THE INCIDENT, THE BLOOD THINNER DOSAGE WAS CHANGED TO 5 MG. THE CAUSE OF THE BLEEDING WAS UNDETERMINED; HOWEVER, AFTER AN APPOINTMENT WITH A UROLOGIST AND PLACEMENT OF THE PATIENT ON A FOLEY CATHETER, THE BLEEDING HAS STOPPED. NO FURTHER BLEEDING EPISODES HAVE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10528364 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem

  THIS CASE CONCERNS A (B)(6) YEAR-OLD MAN (2018), WHO 10 YEARS PREVIOUSLY STARTED INTERMITTENT CATHETERIZATION IN 2008 DUE TO "EXTENDED BLADDER", UNDER THE GUIDANCE OF HIS DOCTOR. IN 2014 - USING SPEEDICATH STRAIGHT- HE DEVELOPED A BLEED (URETHRA?/BLADDER?) WHICH LED TO 2 WEEKS OF HOSPITALIZATION, BLOOD TRANSFUSION AND PLACEMENT OF A FOLEY CATHETER FOR 3 WEEKS; A CAT SCAN DID NOT DISCLOSE THE SITE OF BLEEDING AND THE DOCTOR ASSUMED THAT THE REASON FOR BLEEDING WAS INCORRECT USE OF THE SPEEDICATH CATHETER. SUBSEQUENTLY HE WAS SWITCHED TO A COUDÉ CATHETER AND LATER HE DEVELOPED PEYRONIE´S DISEASE, WHICH ACCORDING TO THE TREATING PHYSICIAN WAS DUE TO THE PROLONGED USE OF THE FOLEY CATHETER. NO FURTHER RELEVANT INFO REGARDING THIS CASE FROM 2014. CONCLUSION: BLEEDING EPISODE DESCRIBED IN CONNECTION TO SPEEDICATH STRAIGHT USE IN 2014 LEADING TO 3 WEEKS PLACEMENT OF A FOLEY CATHETER. REASON FOR SUBSEQUENT DEVELOPMENT OF PEYRONIE´S DISEASE UNCLEAR, BUT ASSESSED TO BE RELATED TO USE OF FOLEY CATHETER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 8604631 ↗
• InjuryMay 13, 2019Patient-Device Incompatibility

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT COULD URINATE BEFORE THE DOCTOR GAVE HIM SOMETHING. HE WAS GIVEN POTASSIUM AFTER SURGERY. LATER THAT NIGHT, THE PATIENT COULDN'T URINATE FOR A COUPLE OF DAYS AND NIGHTS. HE WAS IN PAIN AND WENT TO THE ER. THEY PUT A CATHETER IN AND THE PATIENT WAS ABLE TO GO HOME. THE PATIENT WAS STILL EXPERIENCING PAIN AND RETURNED. HIS UROLOGIST REMOVED THE CATHETER (FOLEY). HE WAS BLEEDING BECAUSE OF ALL THE TROUBLE OF REMOVING THAT FOLEY. THE PATIENT WAS SUPPOSED TO BE USING A COUDÉ AND NOT A STRAIGHT. THERE WAS BLOOD AS A RESULT THIS AND THE PATIENT WAS GIVEN 6 UNITS OF BLOOD. HE HAD SEIZURES DUE TO SO MUCH BLOOD LOSS DUE TO ANEMIA. THE HOSPITAL STAFF COMMENTED THAT THEY DID NOT SUSPECT ANY DEVICE FAILURE.

  Patient problems: Anemia; Blood Loss; Pain; Urinary Retention

  MAUDE report 8604630 ↗
• InjuryNov 12, 2018Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT SAID THAT THE CATHETERS WERE NOT COMPLETELY DRAINING HIS BLADDER, WHICH CONTRIBUTED TO A HOSPITALIZATION.

  Patient problems: No Code Available

  MAUDE report 8061729 ↗
• InjuryFeb 27, 2018Improper or Incorrect Procedure or Method

  ACCORDING TO THE AVAILABLE INFORMATION, THE DISTRIBUTOR SUBMITTED THE FOLLOWING COMPLAINT ON BEHALF OF AN END USER. A PATIENT COMPLAINT REGARDING ITEM# 284140 - LOT# 5976881. PATIENT STATED THAT THE 284140 CATHETERS ARE NOT FLEXIBLE ENOUGH AND CAUSED GAUGING AND BLEEDING. NO MEDICAL INTERVENTION REPORTED. ANSWER PROVIDED BY DISTRIBUTOR: CUSTOMER ALLEGED THAT HE INJURED HIMSELF WITH THE CATHETER. HE DID NOT QUANTIFY THE BLEEDING HOWEVER HE GOT A UTI AND IS ON ANTIBIOTICS. THE DOCTOR PLACED HIM ON A FOLEY AS WELL. THE ADDITIONAL QUESTIONS ASKED WERE: HOW MUCH DID THE END USER BLEED? (WAS IT A LOT, JUST A LITTLE, WE UNDERSTAND IT IS HARD TO JUDGE BUT THIS INFORMATION IS IMPORTANT). BESIDE BLEEDING WAS THERE ANY OTHER HARM (I.E. UTI)? CAN YOU CONFIRM NO SUBSEQUENT MEDICAL INTERVENTION WAS REQUIRED SINCE THE COMPLAINT WAS FILED. HOW LONG HAS THE END USER BEEN USING THE PRODUCT? EIGHT YEARS. HOW MUCH DID THE END USER BLEED? ONLY A LITTLE. SO LITTLE THE END USER DIDN'T KNOW HE WAS BLEEDING. HIS UROLOGIST TOLD HIM. WHAT WAS THE END USER'S METHOD OF CATHING? HE FOLLOWED DIRECTIONS EXACTLY AS INSTRUCTED. END USER HAS BEEN USING OUR CATH #28414 FOR EIGHT YEARS. HE HAD A PROBLEM WITH ONE OF OU

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury; Urinary Tract Infection

  MAUDE report 7299886 ↗
• InjuryFeb 27, 2018Improper or Incorrect Procedure or Method

  ACCORDING TO THE AVAILABLE INFORMATION, THE END USER USED THE CATHETER TO CATH HIMSELF WITHOUT PROPER TRAINING. THE PATIENT STATED THAT HE WAS JUST GIVEN THE CATHETERS FROM A CLINICIAN. THE PATIENT CATHED HIMSELF AND STARTED BLEEDING AND WENT TO EMERGENCY ROOM. THE END USER SAID "DOCTOR TOLD THE END USER TO PUT THE CATHETER THROUGH THE SPERM HOLE. THE PATIENT IS NOW ON A FOLEY CATHETER AND IS ON PAIN MEDICAL. THE LOT NUMBER WAS NOT AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 7299880 ↗
• InjuryJan 31, 2017Material Too Rigid or Stiff; Improper or Incorrect Procedure or Method

  ACCORDING TO THE AVAILABLE INFORMATION, 28414 MADE END USER BLEED. SOUGHT MEDICAL ATTENTION - DR. TOLD END USER IT WAS PROBABLY THE STIFFNESS OF THE CATHETER ALONG WITH IMPROPER USE. DR. WAS NOT CONCERNED AND TOLD END USER TO USE A SOFTER CATHETER. END USER WAS USED TO USING RED RUBBER AND WOULD LIKE A SIMILAR CATHETER - SENT SELF-CATH SOFT TO TRY. ON (B)(6) 2017 END USER INDICATED THAT HE WASN'T USED TO THE STIFFER CATHETER AND INSERTED IT TOO QUICKLY, CAUSING THE BLEEDING. HE HAS LEARNED TO INSERT MORE SLOWLY, AND HAS GONE BACK TO THE RED RUBBER CATHETERS UNTIL HE RECEIVES THE SELF-CATH SOFT TO TRY. THINGS ARE GOING BETTER NOW, AND NO FUTURE PROBLEMS ARE ANTICIPATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6291424 ↗