Hemo-Cath® SL18PRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00884908045444), received between Feb 16, 2017 and Aug 8, 2022 — classified as 1 death, 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (15 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2022Leak/Splash; Leak/Splash

  AFTER 2 MONTHS USAGE, LOW CLEARANCE WAS DETECTED (KT/V BELOW 0.3), CATHETER WAS REMOVED AND CHECKED WITH NSS FLUSH AND FOUND A LEAK ACROSS A AND V LUMENS, CAUSE OF RECIRCULATION. CROSS LUMEN LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15182257 ↗
• MalfunctionApr 13, 2022Break; Leak/Splash; Break; Leak/Splash

  AT THE END OF DIALYSIS SESSION, A NURSE FOUND THE CATHETER WITH A LITTLE CRACK NEAR TO THE CLAMP ON THE VENOUS BRANCH. REPAIR OF THE CATHETER USING A KIT SENT BY THE DISTRIBUTOR. THE REPAIR KIT IS NOT APPROVED FOR USE ON THIS DEVICE AND THERE IS A CONCERN THAT THE DEVICE MAY REQUIRE REPLACEMENT. DIALYSIS CONTINUES WITH THE REPAIRED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14101493 ↗
• MalfunctionMar 3, 2021Break; Break

  PATIENT WAS IMPLANTED WITH THE HEMO-CATH ON (B)(6) 2020. ON (B)(6) 2021 THE PATIENT'S FATHER FOUND THE CATHETER WAS BROKEN WHILE AT HOME. ADDITIONAL INFORMATION SHOWS THE DEVICE WAS BEING USED TO INFUSE CHEMOTHERAPY MEDICATION. BLINATUMOMAB 38.5MCG VIAL BLINCYTO WAS USED. THE ISSUE OCCURRED ON THE 26TH DAY OF A 28 DAY INFUSION TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11406804 ↗
• MalfunctionFeb 9, 2021Leak/Splash; Leak/Splash

  COMMUNICATION PROBLEM BETWEEN THE ARTERIAL WAY AND VENOUS WAY OF THE CATHETER. OPACIFICATION MADE TO CONFIRM INTRALUMINAL COMMUNICATION BETWEEN THE TWO VASCULAR PATHWAYS OF THE CATHETER. CIRCUMSTANCES OF THE OCCURRENCE ARE NOT KNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11304414 ↗
• DeathFeb 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AT 10:15 AM WE WERE CALLED BY A NURSE FOR AN EMERGENCY. WHEN WE ARRIVED WE NOTICED A POOL OF BLOOD (SEVERAL LITERS) ON THE GROUND UNDER THE BED OF MISS (B)(6). THE DOCTOR WHO WAS ALREADY THERE WAS COMPRESSING THE CENTRAL VENOUS CATHETER EMERGENCE POINTS WHILE THE BIO-MEDICAL TECHNICIAN ON SITE BEGAN THE CARDIAC MASSAGE. THE PATIENT WAS ALREADY NOT CONSCIOUS. CALL TO (B)(6) AT 10:20 AM, WHICH ARRIVED AT 10:45 AM. THE DEATH WAS DECLARED AT 11:10 AM. THE (B)(6) DOCTOR WHO ESTABLISHED THE DEATH CERTIFICATE DECLARED THE DEATH SUSPICIOUS, WHICH LED TO THE INTERVENTION OF THE JUDICIAL POLICE AS WELL AS THE SCIENTIFIC POLICE AT THE REQUEST OF THE PROSECUTOR. PHOTOS WERE TAKEN AND STAFF QUESTIONED. THE LINE AS WELL AS THE BRANCH OF THE CENTRAL VENOUS CATHETER STILL CONNECTED TO THE LINE WERE RECOVERED BY THE JUDICIAL POLICE. WE COULD SEE THAT THE GUYING WIRE WAS CUT ABOUT 2CM FROM THE ATTACHMENT. THE BODY LEFT AT 5:10 PM AT THE FORENSIC UNIT.

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

  MAUDE report 11300425 ↗
• MalfunctionDec 3, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE ARTERIAL EXTENSION BALLOONED DURING DIALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10942154 ↗
• MalfunctionDec 1, 2020Leak/Splash; Leak/Splash

  THE MOTHER SAW THE LEAK ON THE CATHETER BECAUSE THE DRESSING WAS WETTED WITH BLOOD. IN THE FLUOROSCOPY A DEFECT COULD BE CLEARLY PROVEN. THEREUPON THE CATHETER WAS EXPLANTED. IN THE EXPLANTED CATHETER WE COULD IDENTIFY A DEFECT IN THE ARTERIAL PART.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10927007 ↗
• MalfunctionApr 23, 2020Leak/Splash; Leak/Splash

  PATIENT WAS IMPLANTED WITH THE 8F HEMO-CATH IN (B)(6) 2019. IN (B)(6) 2020 A LEAK WAS NOTED JUST BELOW THE HUB. FLUOROSCOPY DETECTED A LEAK IN THE LUMEN. THE CATHETER WAS EXCHANGED. IN THE DAYS PRIOR TO THE EVENT, THE SUTURES HAD BECOME LOOSE. MEDICAL STAFF EXAMINED THE DEVICE AFTER EXPLANT AND STATED THE LEAK APPEARS TO BE A HOLE AND NOT A RUPTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9990624 ↗
• MalfunctionAug 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  CRACKED HUB DISCOVERED WITH BACK BLOOD FLOW. VISUALIZED UNDER FLUOROSCOPY AND DYE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8906638 ↗
• MalfunctionAug 13, 2019Leak/Splash; Leak/Splash

  HOLE IN LUMEN.

  Patient problems: Blood Loss

  MAUDE report 8887874 ↗
• MalfunctionAug 13, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  EXTENSION TUBING BALLOONING WHEN PRESSURE APPLIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8887318 ↗
• MalfunctionAug 13, 2019Leak/Splash; Leak/Splash

  HOLE IN BLUE EXTENSION TUBING. IMPLANTED FOR 3 WEEKS.

  Patient problems: No Information

  MAUDE report 8887209 ↗
• MalfunctionJul 12, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE RED AND BLUE LUERS ON THE END OF THE EXTENSION LINES WERE NOTED TO BE LOOSE AT THE POINT OF DISCONNECTION FROM THE DIALYSIS TREATMENT. THE NURSES WERE ABLE TO ROTATE THE HUB IN THE SLEEVE AND IT WAS VISIBLY LOOSE. ALCOHOL PREP PADS ARE USED TO CLEANSE THE LINES, USING A TOTAL OF ABOUT 8-10 PREP PADS DURING THE CONNECTION AND DISCONNECTION PROCESS. MORE PADS ARE USED IF THE PATIENT'S LINE HAS TO BE REVERSED AT ANY POINT DURING TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8785000 ↗
• MalfunctionMar 21, 2019Leak/Splash; Leak/Splash

  CRACKED HUB DISCOVERED WITH BACK BLOOD FLOW. VISUALIZED UNDER FLUOROSCOPY AND DYE. (CROSS LUMEN LEAK).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8439694 ↗
• MalfunctionMar 7, 2019Leak/Splash; Leak/Splash

  CATHETER SPLIT BELOW HUB.

  Patient problems: Blood Loss

  MAUDE report 8398769 ↗
• InjuryJan 3, 2019Break; Break

  DURING A DRESSING CHANGED THE CATHETER WAS NOTED TO BE TWISTED AND NO SUTURES WERE PRESENT IN EITHER OF THE HUB HOLES. THE LINE WAS UNTWISTED AND A DRESSING AND EXTRA TAPE WAS APPLIED TO KEEP THE LINE FLAT. LATER THE PATIENT WAS OUT OF BED. A FAMILY MEMBER LIFTED THE PATIENT UP AND THERE WAS A SLIGHT TUG ON THE LINE. THE STAFF WAS NOTIFIED THAT THE LINE "CAME APART".

  Patient problems: Blood Loss

  MAUDE report 8214295 ↗
• InjuryNov 28, 2018Break; Break

  PATIENT WAS RECEIVING HEMODIALYSIS. NOTED THAT MACHINE WAS ALARMING AND AIR HAD ENTERED CIRCUIT. CRACK IN CATHETER BETWEEN PATIENT AND HUB NOTED WITH ACTIVE BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 8111740 ↗
• MalfunctionJun 14, 2018Leak/Splash; Leak/Splash

  HOLES IN THE EXTENSION OUTSIDE WHERE THE CLAMP IS FIXED.

  Patient problems: Blood Loss

  MAUDE report 7601956 ↗
• MalfunctionFeb 1, 2018Leak/Splash; Leak/Splash

  CATHETER WITH A SIDE HOLE, AND WHILE FLUSHING, SPLASH OCCURRED DUE TO HOLE OR CRACK IN THE DISTANCE BETWEEN EXTENSIONS AND CUFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7233589 ↗
• MalfunctionFeb 1, 2018Leak/Splash; Leak/Splash

  CATHETER HAS A PIN HOLE IN THE EXTENSION TUBING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7233588 ↗
• MalfunctionNov 16, 2017Leak/Splash; Leak/Splash

  WHEN THE NURSE WANTED TO START THE DIALYSIS, SHE OPENED THE CLAMP (RED LUMEN) AND SHE NOTICED DAMAGE/HOLE UNDER THE CLAMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7037422 ↗
• MalfunctionJul 28, 2017Leak/Splash; Leak/Splash

  CATHETER INSERTED WITHOUT EVENT. IN SITU FOR ABOUT 10 DAYS WHEN SOLUTION BEGAN TO SEEP OUT OF THE CATHETER NEAR THE CUFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6750078 ↗
• InjuryJun 14, 2017Break; Failure to Select Signal

  PT. WAS ADMITTED FOR SHOCK. LINE WAS DETERMINED TO BE IN NEED OF REMOVAL. AT BEDSIDE REMOVAL WAS ATTEMPTED, "THE CATHETER SNAPPED" AND SURGICAL EVALUATION WAS OBTAINED. PT. WAS TAKEN TO THE OR FOR REMOVAL OF RETAINED PORTION OF CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6639970 ↗
• MalfunctionMay 11, 2017Fluid/Blood Leak; Hole In Material; Leak/Splash; Leak/Splash

  STAFF NOTICED BLOOD LEAK AND HOLE WAS NOTED ON VENOUS SIDE OF CATHETER JUST BELOW HUB.

  Patient problems: Blood Loss

  MAUDE report 6560710 ↗
• InjuryFeb 16, 2017Material Fragmentation

  DURING CATHETER EXCHANGE THE CATHETER BROKE AT THE HUB AND HAD TO BE RETRIEVED THROUGH THE GROIN ACCESS. THE CATHETER HAS BEEN IN PLACE FOR APPROXIMATELY THREE MONTHS. DURING THE RETRIEVAL PROCEDURE, THE NEW CATHETER BROKE. ALL PIECES WERE EVENTUALLY REMOVED FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6335732 ↗