HEMO-CATH® DMC101242Recalls & reported problems
Medical Components, Inc. · 12.5F X 18CM HEMO-CATH® SILICONE DOUBLE LUMENSILICONE DO BASIC SETBASIC SET (CUFF 13CM FROM TIP)(CUFF 13CM F · Class 2 · Implant
All models of Hemo-Cath (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908140828), received between Jan 6, 2026 and Jan 6, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
Other Catheter, hemodialysis, implanted devices
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- Palindrome 8888145015Mozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death219 reports
- HemoStar Long-Term Hemodialysis Catheter 5833690Bard Access Systems, Inc. · Catheter, hemodialysis, implanted2 deaths290 reports
- Palindrome 8888119369PMozarc Medical US LLC · Catheter, hemodialysis, implanted3 recalls1 death14 reports
- HemoStar Long-Term Hemodialysis Catheter 5833730Bard Access Systems, Inc. · Catheter, hemodialysis, implanted1 death141 reports
- GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5393230Bard Access Systems, Inc. · Catheter, hemodialysis, implanted5 deaths138 reports
- Palindrome 8888123404PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 reports
- Palindrome 8888119364PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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