MAHURKAR 8832539003Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521005358), received between Jul 10, 2019 and Nov 27, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device 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
- Detachment of Device or Device Component1
- Obstruction of Flow1
Patient problems
- No Information2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2019Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE GUIDE WIRE WAS IMPOSSIBLE TO BE INSERTED INTO THE CATHETER DUE TO AN INTERNAL OBSTRUCTION. THE CATHETER WAS NOT REPAIRED AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT BUT NO CLEANING AGENT WAS USED. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: No Information
MAUDE report 9382092 ↗MalfunctionJul 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THERE WERE POSITIVE BLOOD FLOW AND POSSIBLE ADMINISTRATION AT THE TIME WHEN A KINK WAS OBSERVED WHEN THE DRESSING WAS CHANGED. REPOSITIONING WAS MADE AS MUCH AS POSSIBLE AND THEY HELD THE BANDAGE WHEN THEY TESTED THE TRACK. THE BLUE BRANCH WAS DISCONNECTED WHEN IT WAS FLUSHED AND A BLOODY STAIN WAS VISIBLE ON THE BANDAGE WHEN THE HYDRATION WAS CONNECTED. IT WAS STATED THAT THEY HAD TO REMOVE THE DRESSING AND CLAMP THE EXTENSION OF THE BLUE LINE, REMOVE THE CATHETER AND PUT A NEW ONE, COMPRESSION OF THE POINT OF WITHDRAWAL, AND THE PATIENT WAS IN A SUPINE DECAY (A POSITION GIVEN TO A PATIENT FOR THE CHANGE OF CATHETER). THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. IT WAS STATED THAT THERE WAS A RISK OF GAS EMBOLISM WHICH WAS AVOIDED BY COMPRESSION AND IMMEDIATE SLOPE, PATIENT ANXIETY, AND "POST-MORTEM MEDICAL SURVEILLANCE, SEARCH FOR HEART SIGNS D AND ECG". THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 8778780 ↗
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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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