MAHURKAR 8832539001Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521005303), received between Jan 27, 2022 and Apr 21, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (3 reports).
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
- Insufficient Flow or Under Infusion3
- Device Markings/Labelling Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Unintended Radiation Exposure1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
ACCORDING TO THE REPORTER, THE CATHETER KEPT CLOTTING OFF. THE ISSUE WAS THE CATHETER WAS NOT ABLE TO PERFORM DIALYSIS. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 21872972 ↗MalfunctionApr 21, 2025Insufficient Flow or Under Infusion; Device Markings/Labelling Problem; Insufficient Flow or Under Infusion; Device Markings/Labelling Problem
ACCORDING TO THE REPORTER, THE NURSE WANTED TO PRIME THE CATHETER WITH TPA (TISSUE PLASMINOGEN ACTIVATOR) BECAUSE THE CATHETER KEPT CLOTTING OFF. THE PROBLEM WAS A DISCREPANCY IN THE PRIMING VOLUMES. ON THE BACK END OF THE CATHETER, IT STATED THAT RED WAS 0.7 CC (CUBIC CENTIMETER) AND BLUE WAS 0.7 CC. WHEN THEY PULLED THE PRINTED IFU (INSTRUCTIONS FOR USE) FROM THE CASE, THE PRIMING VOLUMES ALSO STATED RED 0.7 CC AND BLUE 0.7 CC. THE NURSE AND THE TEAM HAD RESEARCHED THE INTERNET AND FOUND ANOTHER IFU THAT STATED SOMETHING DIFFERENT. IT STATED THE RED WAS 0.8 CC AND THE BLUE WAS 0.9 CC. THE NURSE WAS INSTRUCTED TO USE THE IFU WITH THE PRIMING VOLUMES RED 0.8 CC AND BLUE 0.9 CC, AS THE CATHETER HAD BEEN DESIGNED WITH A STAGGERED TIP IN WHICH THE VENOUS (BLUE) LUMEN WAS MORE DISTAL THAN THE ATRIAL (RED) LUMEN, THUS BOTH LUMENS COULD NOT HAVE HAD THE SAME PRIMING VOLUME. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872868 ↗InjuryJan 27, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
ACCORDING TO THE REPORTER, A PEDIATRIC PATIENT OF (B)(6) WITH CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD), HOSES FROM HF20 SET WERE CONNECTED DIRECTLY TO CDK OF 8FR, 9CM. THEY HAD NOT MADE ANY INTERCONNECTIONS. WHEN THEY HAD STARTED THE CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT), THEY OBSERVED PROBLEMS WITH NEGATIVE OUTPUT PRESSURE. THE NURSE HAD TRIED TO RESOLVE THE PROBLEM BY REDUCING THE BLOOD FLOW, WHICH HAS WORKED FOR A SHORT TIME AND SUDDENLY, AIR HAS BEEN DETECTED IN CDK LADLE AND HF20 OUTPUT HOSE. THE TREATMENT HAS BEEN DISCONTINUED AND THE CDK ASPIRATIONAL AND CONTROL WAS X-RAYED. THEY HAVE SLIGHTLY CHANGED THE POSITION OF THE CDK (MORE SUPERFICIAL) AND THEY WERE NOT ABLE TO PUSH IN ANYMORE AND DECIDED TO PULL CDK. THERE WAS AN ABOUT 50-60 ML OF BLOOD LOSS. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Unintended Radiation Exposure
MAUDE report 13376336 ↗
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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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