Hemo-CathRecalls & reported problems across all models
Medical Components, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 42
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls
- 0
We found 10 models of Hemo-Cath by Medical Components, Inc. in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2017 and Jan 22, 2026 — classified as 1 death, 8 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (23 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
Reports received per month, all models
Most reported Hemo-Cath problems
Device problems
- Leak/Splash23
- Break9
- Appropriate Device Problem Term/Code Not Available4
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem1
- Air/Gas in Device1
- Crack1
- Disconnection1
Patient problems
- No Known Impact Or Consequence To Patient17
- No Clinical Signs, Symptoms or Conditions11
- Blood Loss6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Cardiac Arrest1
- Chest Pain1
- Device Embedded In Tissue or Plaque1
- Dyspnea1
Hemo-Cath models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hemo-Cath® SL18PCATHETER, SUBCLAVIAN1 death25 reports
- Hemo-Cath® SL12PCATHETER, SUBCLAVIAN3 reports
- HEMO-CATH® MC101042PCatheter, hemodialysis, implanted3 reports
- HEMO-CATH® DMC101243Catheter, hemodialysis, implanted3 reports
- Hemo-Cath® MCDLTSL18PCATHETER, SUBCLAVIAN2 reports
- Hemo-Cath® SL28Catheter, hemodialysis, implanted2 reports
- Hemo-Cath® SL15CATHETER, SUBCLAVIAN1 report
- HEMO-CATH® MC101041PCatheter, hemodialysis, implanted1 report
- Hemo-Cath® MC101045PCatheter, hemodialysis, implanted1 report
- HEMO-CATH® DMC101242Catheter, hemodialysis, implanted1 report
Recent Hemo-Cath adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Leak/Splash
PATIENT RECEIVED NEW HD CATHETER (B)(6) 2026, THE LINE WAS ACCESSED AND USED FOR HEMODIALYSIS BOTH (B)(6) 2026 AND (B)(6) 2026 WITHOUT ISSUE. WHEN LINE ACCESSED (B)(6) 2026, NOTED PIN PRICK SPRAY/LEAK FROM BOTH RED AND BLUE LUMENS. NEPHROLOGIST NOTIFIED, LABS COLLECTED. AFTER REVIEWING LABS NEPHROLOGIST DETERMINED LABS ARE STABLE AND DIALYSIS WAS NOT URGENT. IR TEAM CONTACTED DIRECT BY NEPHROLOGIST FOR NEW LINE PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24145159 ↗MalfunctionJan 6, 2026Leak/Splash
WHEN PERFORMING ROUTINE FLUSHING HEMODIALYSIS CATHETER, 2 PINHOLES NOTED TO EXTERNAL PORTION OF BLUE LIMB OF CATHETER LUMEN. MD NOTIFIED IMMEDIATELY AND CENTRAL VENOUS LINE WAS LOCKED WITH NORMAL SALINE. URGENT VASCATH REPLACEMENT PERFORMED. THE FOLLOWING DAY DAYSHIFT BEDSIDE RN NOTICED SMALL AMOUNT OF BLOOD ON OUTSIDE CIRCUMFERENCE OF BLUE LUMEN OF NEWLY IR PLACED TUNNELED DIALYSIS CATHETER. UPON FURTHER INSPECTION, A SMALL PINHOLE WAS NOTED ON THE EXTERNAL PORTION OF THE BLUE LUMEN. MD IMMEDIATELY NOTIFIEC AS WELL AS IR AND PEDS NEPHROLOGIST.
Patient problems: Insufficient Information
MAUDE report 23975778 ↗MalfunctionJun 22, 2023Leak/Splash; Leak/Splash
DURING DIALYSIS CATHETER WAS NOT FUNCTIONING AND A LEAK WAS NOTED. AFTER REMOVAL A LEAK WAS NOTED PROXIMAL TO THE CUFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17180903 ↗InjuryMar 30, 2023Break; Break
UPON THE PATIENT HAVING AN ECHO, IT WAS NOTICED THAT THE TIP OF THE CATHETER LINE HAD BROKEN OFF AND HAD BECOME LODGED IN HIS RIGHT PULMONARY ARTERY. CARDIAC SURGEONS HAVE RECOMMENDED WE LEAVE IT IN SITU AS OPERATING TO REMOVE IT IS MORE DANGEROUS THAN LEAVING IT IN.
Patient problems: Foreign Body In Patient
MAUDE report 16644360 ↗MalfunctionMar 10, 2023Leak/Splash; Leak/Splash
DURING CLEANING PROCEDURE TWO (2) HOLES WERE MADE IN THE CATHETER LUMEN. THE CATHETER WAS CHANGED ACCORDINGLY. DEVICE WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16521387 ↗MalfunctionJan 20, 2023Leak/Splash; Leak/Splash
UPON ROUTINE ASSESSMENT OF THE PATIENT FOR DIALYSIS, SPOTS OF FRANK BLOOD NOTED ON PATIENT'S SHIRT. FURTHER INSPECTION OF THE CATHETER REVEALED A PIN HOLE DEFECT ON THE ARTERIAL PORT OF THE HEMODIALYSIS CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16216055 ↗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 ↗InjuryApr 12, 2022Break; Break
EXIT SUTURE DUE FOR REMOVAL FROM MEDCOMP CENTRAL LINE. SUTURE WRAPPED TIGHTLY AROUND LINE, USED A SUTURE REMOVAL KIT. AFTER SUTURE REMOVAL PATIENT BECAME ANXIOUS, SHORT OF BREATH, WITH CHEST DISCOMFORT. DR. CAME AND ASSESSED PLACED IMMEDIATELY ON OXYGEN AND PLACED ON HER RIGHT SIDE. WE WERE ABLE TO DETERMINE THAT THERE WAS AIR IN LUMEN OF CENTRAL LINE, LATER FOUND A SMALL HOLE IN LINE NEAR EXIT SITE. LINE PROMPTLY REMOVED BY MD. PT KEPT FOR 2 HOURS POST LINE REMOVAL AND WAS DISCHARGED FROM CLINIC STABLE. PLACED ON OXYGEN AND PLACED ON RIGHT SIDE CENTRAL LINE IMMEDIATELY REMOVED. ONCE LINE REMOVED SYMPTOMS RESOLVED.
Patient problems: Chest Pain; Dyspnea
MAUDE report 14084335 ↗MalfunctionNov 7, 2021Leak/Splash; Leak/Splash
A PORE APPEARED IN THE CATHETER EXTENSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12760498 ↗InjurySep 9, 2021Break; Break
DURING INSERTION, AFTER BLOOD WAS ASPIRATED USING THE NEEDLE PROVIDED, THE WIRE WAS FED THROUGH. INITIALLY FED EASILY AND THEN MET RESISTANCE. THE ULTRASOUND SHOWED THE WIRE HAD GONE INTO THE INTERNAL JUGULAR AND THROUGH THE POSTERIOR WALL. THE NEEDLE WAS REMOVED AND THEN THE WIRE WAS PULLED BACK, MAJORITY PULLED BACK EASILY BUT THEN MET RESISTANCE. ULTRASOUND SHOWED THE WIRE WAS STUCK TO THE POSTERIOR WALL OF INTERNAL JUGULAR. ON CLOSER INSPECTION OF WIRE THE INNER COIL PART HAD SEPARATED FROM OUTER FIRM PART, AND SUBSEQUENTLY THE COIL WAS STUCK IN THE VEIN MAKING IT IMPOSSIBLE TO REMOVE WITH GENTLE TRACTION. VASCULAR SURGERY CONTACTED AND PATIENT REQUIRED SURGICAL CUT DOWN TO REMOVE WIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12445699 ↗MalfunctionAug 24, 2021Leak/Splash; Leak/Splash
LEAKAGE FROM THE EXTENSION TUBE WAS DISCOVERED WHILE FLUSHING THE CATHETER PRIOR TO HEMODIALYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12358886 ↗MalfunctionApr 15, 2021Air/Gas in Device; Air/Gas in Device
THE BLUE LUMEN OF THE APHERESIS LINE WAS ACCESSED PER POLICY. THE RED LUMEN OF THE CATHETER WAS NOTED TO HAVE AIR IN IT. PATIENT STATED THAT THERE WAS AIR OBSERVED IN THE LINE THE WEEK BEFORE ALSO. SHE DENIES THE CAP COMING OFF OR ANY NOTABLE LEAKAGE. NO CRACKS WERE VISIBLE IN THE LINE BY THE APHERESIS UNIT NURSES OR SURGERY TEAM WHO CAME TO CONSULT WHEN THE AIR WAS DISCOVERED. DRESSING REMOVED BY SURGERY TEAM, HEPARIN DWELL REMOVED, AND LINE FLUSHED WITH NS WHILE THE GENERAL SURGERY RESIDENT, PA AND RN WATCHED FOR LEAKING. NO LEAKS NOTED. DUE TO UNEXPLAINED RECURRENCE OF AIR IN THE LINE AND RISK FOR HARM, A PLAN WAS MADE FOR THE CENTRAL LINE TO BE REMOVED IN THE OR. THE LINE WAS REMOVED WITHOUT COMPLICATIONS BUT THE LINE WAS NOT SAVED BY THE SURGERY TEAM IN THE OR SO WE ARE UNABLE TO SEQUESTER THE LINE FOR EXAMINATION BY THE COMPANY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11674733 ↗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 ↗
Other Medical Components, Inc. products
All Medical Components, Inc. 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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