MAHURKAR Elite 8888211220Recalls & reported problems
Mozarc Medical US LLC · Acute Dual Lumen Catheter Kit,High Flow Straight Extensions,13.5 Fr/Ch (4.5 mm) x 20 cm · Class 2
All models of MAHURKAR Elite (64)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521125384), received between May 20, 2025 and May 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unraveled Material” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K120674); they may or may not involve this specific model.
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
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2025Unraveled Material; Unraveled Material
ACCORDING TO THE REPORTER, DURING CATHETERIZATION, THE GUIDEWIRE LOST ITS ¿TEXTURE¿ AND FELT PARTICULARLY ¿SOFT,¿ COILED AND UNRAVELED, AND GREATLY IMPACTED THE QUALITY OF THE PROCEDURE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE PRODUCT WAS NOT REPLACED AS REMEDIAL ACTION, BUT THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22057101 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K120674. One submission often covers many models, so check the product and lot details in each record.
- Z-2319-2026 · Apr 29, 2026 · Open, ClassifiedMahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen
- Z-1007-2018 · Oct 14, 2017 · TerminatedMAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Other CATHETER, HEMODIALYSIS, NON-IMPLANTED devices
- MAHURKAR 8888135191Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall175 reports
- MAHURKAR 8888135241Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall1 death100 reports
- ARROW IPN036723Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls2 reports
- ARROW IPN036412Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- DuoGlide catheter 5625240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- ARROW IPN036428Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls0 reports
- ARROW IPN036419Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls0 reports
- ARROW IPN927343Teleflex Incorporated · Catheter, hemodialysis, non-implanted2 recalls0 reports
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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