HEMO-FLOW® DHFS 28Recalls & reported problems
Medical Components, Inc. · 14.5F X 28CM HEMO-FLOW® DOUBLE LUMEN CATHETER SETDOUBLE (CUFF 23CM FROM TIP)(CUFF 23CM F · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908140996), received between Jul 18, 2024 and Jan 16, 2025 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2025
RED END OF TUNNEL HD CATHETER FLUSHED WELL, BUT UPON TRYING TO PUT YELLOW END CAPS THEY WOULD NOT THREAD ON DESPITE NUMEROUS ATTEMPTS, FAULTY THREADS. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21167509 ↗MalfunctionJul 18, 2024
ELDERLY MALE WITH CORONARY ARTERY DISEASE AND RECENT BLEED FROM DIALYSIS CATHETER. PROCEDURE: TUNNELED HEMODIALYSIS VENOUS CATHETER PLACEMENT WITH FLUOROSCOPY AND ULTRASOUND. THE DISTAL CATHETER SPLIT WHEN PUTTING THE TUNNELER ON. REMOVED AND NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CATHETER, HEMODIALYSIS, IMPLANTED, HEMO-FLOW (PER SITE REPORTER). WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19770671 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.