MAHURKAR 8832539002Recalls & reported problems
Mozarc Medical US LLC · Acute Dual Lumen Catheter Kit,Straight Extensions · Class 2
All models of MAHURKAR (81)
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 20884521005317), received between Dec 13, 2024 and Dec 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Break; Break
ACCORDING TO THE REPORTER, THE CHILD REQUIRED PLASMA EXCHANGE TREATMENT DUE TO HYPERCHOLESTEROLEMIA. ON (B)(6) 2024, HE WAS TRANSFERRED TO THE PEDIATRIC ICU FOR ULTRASOUND-GUIDED CENTRAL VENOUS CATHETERIZATION. AN 8FR HEMODIALYSIS CATHETER WAS INSERTED AT 10:00 WITH A DEPTH OF 10 CM. THE ASPIRATION WAS SMOOTH, AND THE INFUSION WAS UNOBSTRUCTED. THE CATHETER WAS FLUSHED WITH NORMAL SALINE AND LOCALLY FIXED. THE VITAL SIGNS WERE STABLE DURING THE OPERATION, AND THERE WAS NO OBVIOUS BLEEDING FROM THE PUNCTURE SITE AFTER THE OPERATION. AT 15:00, THE HEMODIALYSIS CATHETER WAS ASPIRATED BEFORE THE PLASMA EXCHANGE OPERATION, AND A CRACK WAS FOUND IN THE HEMODIALYSIS CATHETER. AFTER RE-DISINFECTION AND DRAPING, AFTER A GUIDE WIRE WAS INSERTED AT THE ORIGINAL HEMODIALYSIS CATHETER, THE ORIGINAL HEMODIALYSIS CATHETER WAS REMOVED. THE CATHETER HAD BEEN PLACED FOR FIVE HOURS. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS A CRACK ON THE LUER ADAPTER. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. THE INSERTION SI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20926339 ↗
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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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