MAHURKAR 8813794009Recalls & reported problems
Mozarc Medical US LLC · Acute Dual Lumen Catheter,Curved Extensions with 2 Sealing Caps · 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521004863), received between May 31, 2022 and Aug 17, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break3
- Material Deformation3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Inflammation3
- Skin Discoloration3
- Unspecified Infection3
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2022Break; Material Deformation; Break; Material Deformation
ACCORDING TO THE REPORTER, AFTER THE VASCULAR ACCESS WAS INSERTED, A FEW DAYS LATER, THE PATIENT PRESENTED SYMPTOMS SUCH AS CHANGE IN SKIN COLOR, INFLAMMATION AND FIBRIN FORMATION. THE CLIENT SUGGESTED AN INFECTION WITH THESE SYMPTOMS. IT WAS ALSO STATED THAT THE CATHETER'S PROXIMAL PART WAS RUPTURED (BROKEN). THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK AND THERE WAS NO LUER ADAPTER ISSUE. THE DEVICE WAS REPLACED AS REMEDIAL ACTION. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO OTHER INJURY AS THE RESULT OF THE EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Skin Discoloration; Unspecified Infection
MAUDE report 15239327 ↗InjuryAug 16, 2022Break; Material Deformation; Break; Material Deformation
ACCORDING TO THE REPORTER, AFTER THE VASCULAR ACCESS WAS INSERTED, A FEW DAYS LATER, THE PATIENT PRESENTED SYMPTOMS SUCH AS CHANGE IN SKIN COLOR, INFLAMMATION AND FIBRIN FORMATION. THE CLIENT SUGGESTED AN INFECTION WITH THESE SYMPTOMS. IT WAS ALSO STATED THAT THE CATHETER'S PROXIMAL PART WAS RUPTURED (BROKEN). THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT'S HOSPITALIZATION. THE PRODUCT WAS REPLACED. THERE WAS NO OTHER INJURY AS THE RESULT OF THE EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Skin Discoloration; Unspecified Infection
MAUDE report 15233573 ↗InjuryMay 31, 2022Break; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Material Deformation; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, A FEW DAYS LATER AFTER THE VASCULAR ACCESS WAS INSERTED, THE PATIENT PRESENTED SYMPTOMS SUCH AS SKIN COLOR CHANGE (RED SKIN), INFLAMMATION, AND FIBRIN FORMATION. THEY REPORTED SYMPTOMS OF INFECTION AT THE INSERTION SITE AND PAIN. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Pain; Skin Discoloration; Unspecified Infection
MAUDE report 14548693 ↗
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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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