MAHURKAR 8830416003Recalls & reported problems
Mozarc Medical US LLC · Acute Dual Lumen Catheter Tray Curved Extensions with IC Components · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521005228), received between Jul 14, 2020 and Jul 14, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Puncture/Hole” (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.
Most reported problems
Device problems
- Material Puncture/Hole1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 2020Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE REPORTER, THE CATHETER WAS PLACED AND AN X-RAY CONFIRMED THE PLACEMENT. CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS STARTED WITH NO COMPLICATIONS. THE PULSE OXIMETER STARTED NOT TO BE ABLE TO PICK UP AND THE BLOOD PRESSURE (BP) STARTED DECREASING. WHEN TWO NURSES DID FULL ASSESSMENT, IT WAS NOTED THAT THERE WAS BLOOD OUTSIDE OF THE EXTENSION TUBE OF THE BLUE (VENOUS) TUBING AND A SMALL HOLE WAS FOUND IN THE EXTENSION TUBE NEXT TO THE BLUE LUER ADAPTER UPON CLOSER INSPECTION. THE BLOOD WAS ONLY NOTICEABLE ON THE EXTERNAL CATHETER EXTENSION TUBING WHEN TOUCHED AND IT WAS A VERY MINIMAL AMOUNT OF BLOOD. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LUER ADAPTER ISSUE. CRRT WAS STOPPED IMMEDIATELY AND THE PHYSICIAN WAS CALLED. THE PATIENT CONTINUED TO GET WORSE AND A CODE WAS CALLED. CATHETER WAS REMOVED WHEN THE PATIENT'S CONDITION WAS STABILIZED.
Patient problems: No Code Available
MAUDE report 10270710 ↗
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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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