MAHURKAR Elite 8888231416 (UDI 10884521127531)Recalls & reported problems
Mozarc Medical US LLC · Acute Triple Lumen Catheter Tray,Straight Extensions with IC* Safety Components,12.5 Fr/Ch (4.2 mm) x 16 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 10884521127531), received between Mar 18, 2025 and Mar 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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
- Insufficient Flow or Under Infusion1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
ACCORDING TO THE REPORTER, THE CATHETER ALERTED POSITIVE AND NEGATIVE PRESSURE. A NEW CATHETER WAS PLACED WITH NO ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 21632511 ↗
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, TRIPLE LUMEN, NON-IMPLANTED devices
- Power-Trialysis catheter 5605150Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls13 reports
- Power-Trialysis catheter 5605240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls8 reports
- MAHURKAR 8888101002HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls1 death8 reports
- Power-Trialysis Slim-Cath catheter 5855240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- Power-Trialysis catheter 5615200Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- MAHURKAR 8888101003HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- MAHURKAR 8888102003HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls4 reports
- MAHURKAR 8888102004HPMozarc Medical US LLC · CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 recalls3 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.
How reports and recalls are matched · Editorial policy · Report an error on this page