MAHURKAR 8817143005Recalls & reported problems
Mozarc Medical US LLC · Acute Dual Lumen Catheter Kit,Curved Extensions · Class 2
All models of MAHURKAR (81)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521005006), received between Nov 14, 2018 and Nov 11, 2024 — classified as 1 injury, 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
- Material Puncture/Hole1
Patient problems
- Air Embolism1
- No Clinical Signs, Symptoms or Conditions1
- Radiation Exposure, Unintended1
- Tachycardia1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2024Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE REPORTER, DURING NORMAL USE, THERE WAS A LEAK AND HOLE AT THE JUNCTION OF THE VENOUS EXTENSION TUBE AND BIFURCATE. THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LUER ADAPTER ISSUE. AS A REMEDIAL ACTION, THE CATHETER WAS IMMEDIATELY REPLACED WITH ANOTHER ONE WITH THE SAME PRODUCT ID. THE PATIENT HAD BLEEDING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652596 ↗InjuryNov 14, 2018Break; Break
ACCORDING TO THE REPORTER, QUICKLY AFTER THE START OF THE PLASMAPHERESIS SESSION ON THE PATIENT, A PRESENCE OF AIR IN THE ARTERIAL PATHWAY WAS DETECTED BY THE MACHINE. THEY STOPPED THE TREATMENT, CLAMPED THE CHANNELS AND WITHDRAWAL OF AIR IN THE CATHETER USING A SYRINGE WAS PERFORMED. IT WAS STATED THAT THE PHYSICIAN DECIDED TO HAVE THE DRESSING REPAIRED AND CHANGE THE TIP OF THE ARTERIAL PATHWAY DUE TO A SUSPECTED CRACK. AT THE MOMENT OF CATHETER CARE, IT WITHDREW ALONE AND THE PATIENT RAPIDLY PRESENTED RESPIRATORY DISTRESS AND VERY RAPID ONSET OF TACHYCARDIA THEN DESATURATION. SUSPICION OF A GAS EMBOLISM WAS CONFIRMED BY SCAN.
Patient problems: Air Embolism; Radiation Exposure, Unintended; Tachycardia
MAUDE report 8068032 ↗
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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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