MAHURKAR 8817146001Recalls & 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
- 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 10884521005020), received between Jul 24, 2018 and Nov 24, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
- Difficult to Advance1
- Difficult to Remove1
- Obstruction of Flow1
- Stretched1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- Radiation Exposure, Unintended1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2021Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE REPORTER, IT WAS SAID THAT THEY TESTED THE CATHETER PRIOR TO INSTALLATION/USE, SO THE GUIDEWIRE WAS PASSED THROUGH ONE OF THE LUMENS (NOT SPECIFIED WHICH LUMEN) BUT THEY NOTICED THAT IT DID NOT PASS, SO THEY DECIDED NOT TO USE THE CATHETER. IT WAS SAID THAT THE CATHETER WAS OCCLUDED BUT IT WAS NOT ALSO SPECIFIED WHICH OF THE LUMENS WAS. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE DURING VISUAL INSPECTION. NO PACKAGE DAMAGE WAS NOTED. THE STERILE BARRIER WAS INTACT. THE BOX THAT THE DEVICE CAME IN WAS INTACT. THE CATHETER WAS NOT REPAIRED. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THE CATHETER WAS DISCARDED AND THEY REQUESTED AND PULLED OUT A NEW ONE WITH THE SAME BRAND AND CHARACTERISTICS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12868609 ↗InjuryJul 24, 2018Difficult to Remove; Stretched; Defective Component; Difficult to Advance; Difficult to Remove; Difficult to Advance
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN IMPLANTING THE CATHETER FOR PLASMAPHERESIS, THE GUIDE WIRE PRESENTED A DEFECT. IT WAS STATED THAT THE GUIDE WIRE WAS STRETCHED AND IT DID NOT LEAVE THE CATHETER. IT WAS NECESSARY FOR ITS WITHDRAWAL AND FOR A NEW PASSAGE. THE PHYSICIAN HAD TO PERFORM THE CATHETER REPLACEMENT AND INSERT IT AGAIN SO THAT THE PATIENT COULD HAVE HEMODIALYSIS SESSION. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient; Radiation Exposure, Unintended
MAUDE report 7714509 ↗
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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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