MAHURKAR EliteRecalls & reported problems across all models
Mozarc Medical US LLC · 64 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MAHURKAR Elite model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 148
- Deaths reported
- 6
- Injuries reported
- 23
- Recalls
- 2
We found 64 models of MAHURKAR Elite by Mozarc Medical US LLC in the FDA's device registry (GUDID). Together they are named in 148 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2017 and May 11, 2026 — classified as 6 deaths, 23 injuries, 119 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (45 reports).
2 FDA recall records name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MAHURKAR Elite recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 29, 2026Open, Classified
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Z-2319-2026 · Root cause: Under Investigation by firm · names 26 of these models · Recall details · FDA record ↗
- Oct 14, 2017Terminated
Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays was inadvertently shipped to Medtronic and distributed without being sterilized.
Z-1007-2018 · Root cause: Process control · Recall details · FDA record ↗
Most reported MAHURKAR Elite problems
Device problems
- Obstruction of Flow45
- Product Quality Problem29
- Difficult to Remove28
- Break17
- Unraveled Material12
- Insufficient Flow or Under Infusion9
- Defective Component7
- Material Frayed7
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- Insufficient Information36
- No Consequences Or Impact To Patient14
- No Patient Involvement10
- Foreign Body In Patient7
- No Information5
- Radiation Exposure, Unintended5
- Unintended Radiation Exposure5
MAHURKAR Elite models
64 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MAHURKAR Elite 8888211424Catheter, hemodialysis, non-implanted1 recall2 reports
- MAHURKAR Elite 8888233420Catheter, hemodialysis, triple lumen, non-implanted1 recall2 reports
- MAHURKAR Elite 8888222316CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall1 death1 report
- MAHURKAR Elite 8888231420Catheter, hemodialysis, triple lumen, non-implanted1 recall1 report
- MAHURKAR Elite 8888231424Catheter, hemodialysis, triple lumen, non-implanted1 recall1 report
- MAHURKAR Elite 8888233416Catheter, hemodialysis, triple lumen, non-implanted1 recall1 report
- MAHURKAR Elite 8888211413Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888211416Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888211420Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888212413Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888212416Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888212420Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888213416Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888213420Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888221413Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888221416Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888221420Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888221424Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888221430Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888222416Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888222420Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888222424Catheter, hemodialysis, non-implanted1 recall0 reports
- MAHURKAR Elite 8888231413Catheter, hemodialysis, triple lumen, non-implanted1 recall0 reports
- MAHURKAR Elite 8888231416Catheter, hemodialysis, triple lumen, non-implanted1 recall0 reports
- MAHURKAR Elite 8888231430Catheter, hemodialysis, triple lumen, non-implanted1 recall0 reports
- MAHURKAR Elite 8888233413Catheter, hemodialysis, triple lumen, non-implanted1 recall0 reports
- MAHURKAR Elite 8888233424Catheter, hemodialysis, triple lumen, non-implanted1 recall0 reports
- MAHURKAR Elite 8888233216CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED38 reports
- MAHURKAR Elite 8888221220CATHETER, HEMODIALYSIS, NON-IMPLANTED1 death18 reports
- MAHURKAR Elite 8888223216CATHETER, HEMODIALYSIS, NON-IMPLANTED8 reports
- MAHURKAR Elite 8888222220CATHETER, HEMODIALYSIS, NON-IMPLANTED7 reports
- MAHURKAR Elite 8888222216CATHETER, HEMODIALYSIS, NON-IMPLANTED6 reports
- MAHURKAR Elite 8888211224CATHETER, HEMODIALYSIS, NON-IMPLANTED4 reports
- MAHURKAR Elite 8888223220CATHETER, HEMODIALYSIS, NON-IMPLANTED4 reports
- MAHURKAR Elite 8888211216CATHETER, HEMODIALYSIS, NON-IMPLANTED3 reports
- MAHURKAR Elite 8888221213CATHETER, HEMODIALYSIS, NON-IMPLANTED3 reports
- MAHURKAR Elite 8888221224CATHETER, HEMODIALYSIS, NON-IMPLANTED3 reports
- MAHURKAR Elite 8888211416CATHETER, HEMODIALYSIS, NON-IMPLANTED3 reports
- MAHURKAR Elite 8888211420CATHETER, HEMODIALYSIS, NON-IMPLANTED3 reports
- MAHURKAR Elite 8888221320CATHETER, HEMODIALYSIS, NON-IMPLANTED3 reports
- MAHURKAR Elite 8888221420CATHETER, HEMODIALYSIS, NON-IMPLANTED1 death3 reports
- MAHURKAR Elite 8888231230CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED3 reports
- MAHURKAR Elite 8888233220CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED3 reports
- MAHURKAR Elite 8888211230CATHETER, HEMODIALYSIS, NON-IMPLANTED2 reports
- MAHURKAR Elite 8888213216CATHETER, HEMODIALYSIS, NON-IMPLANTED2 reports
- MAHURKAR Elite 8888221216CATHETER, HEMODIALYSIS, NON-IMPLANTED2 reports
- MAHURKAR Elite 8888221316CATHETER, HEMODIALYSIS, NON-IMPLANTED2 reports
- MAHURKAR Elite 8888231220CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 reports
- MAHURKAR Elite 8888231324CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 reports
- MAHURKAR Elite 8888233320CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED2 reports
- MAHURKAR Elite 8888211220CATHETER, HEMODIALYSIS, NON-IMPLANTED1 report
- MAHURKAR Elite 8888221130CATHETER, HEMODIALYSIS, NON-IMPLANTED1 report
- MAHURKAR Elite 8888223213CATHETER, HEMODIALYSIS, NON-IMPLANTED1 report
- MAHURKAR Elite 8888211320CATHETER, HEMODIALYSIS, NON-IMPLANTED1 death1 report
- MAHURKAR Elite 8888222320CATHETER, HEMODIALYSIS, NON-IMPLANTED1 report
- MAHURKAR Elite 8888231216CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 death1 report
- MAHURKAR Elite 8888231316CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 report
- MAHURKAR Elite 8888231320CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 report
- MAHURKAR Elite 8888231330CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 death1 report
- MAHURKAR Elite 8888231416CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 report
- MAHURKAR Elite 8888233213CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 report
- MAHURKAR Elite 8888233224CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 report
- MAHURKAR Elite 8888233313CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 report
- MAHURKAR Elite 8888233316CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED1 report
Recent MAHURKAR Elite adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Product Quality Problem; Unraveled Material
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DISTRIBUTOR REPORTS THAT THEIR CLIENT WAS HAVING TROUBLE WITH THE GUIDE WIRE BENDING WITH DIFFICULTY, THE GUIDEWIRE BECAME STUCK IN THE LUMEN. THE GUIDEWIRE WAS STILL INTACT. NOTHING¿UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. BESIDES THE REPORTED ISSUE, THERE WERE NO VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO REMEDIAL ACTION WITH THE REPORTED PRODUCT, HOWEVER THE PROCEDURE WAS COMPLETED USING GUIDEWIRE FROM A DIFFERENT BRAND OF CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 25142209 ↗MalfunctionFeb 5, 2026Unraveled Material
ACCORDING TO THE REPORTER, A PUNCTURE WAS PERFORMED ACCORDING TO THE OPERATIONAL STANDARD. WHEN USING THE GUIDEWIRE FROM THE HIGH-FLOW CATHETER KIT, THE PHYSICIAN OBSERVED KNOTTING OF THE GUIDEWIRE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. MEDICAL OR SURGICAL INTERVENTION WAS NOT NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. AS A RESULT, IT WAS NECESSARY TO REQUEST A UNILUMEN CATHETER AND ANOTHER HIGH-FLOW CURVED CATHETER KIT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24269775 ↗MalfunctionJan 29, 2026Insufficient Flow or Under Infusion
ACCORDING TO THE REPORTER, WITHIN 48 HOURS OF INSTALLATION, THE CATHETER HAD DYSFUNCTION DUE TO HIGH-PRESSURE PROBLEMS. THIS RESULTED IN INADEQUATE BLOOD FLOW AND POOR DIALYSIS. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. REINSTALLING THE CATHETER WAS THE IMMEDIATE ACTION. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 24211418 ↗InjuryDec 12, 2025Difficult to Remove; Difficult to Remove
ACCORDING TO THE REPORTER, AFTER INSERTING THE NEEDLE INTO THE VEIN AND INSERTING THE GUIDE WIRE, THE NEEDLE GOT STUCK IN THE GUIDE WIRE AND WAS NOT REMOVED. BOTH TWO KITS HAD THE SAME ISSUE AND WERE USED ON THE SAME PATIENT. BOTH KITS WERE OBSERVED DURING THE SAME EVENT. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE GUIDEWIRE WAS PROVIDED WITH THE KIT BEING USED. THE GUIDE WIRE WAS NEITHER FRAYED, COILED, NOR UNRAVELED. THE PUNCTURE NEEDLE WAS PROVIDED WITH THE KIT BEING USED. FLUSHING WAS DONE PRIOR TO USE, BUT THE RESULT WAS NOT PROVIDED. THE GUIDE WIRE WAS REMOVED AT THE SAME TIME AS THE NEEDLE, AND IT REMAINED INTACT WHEN REMOVED. THE KIT WAS REPLACED. THE PROCEDURE WAS COMPLETED. THERE WAS BLOOD LOSS, BUT NO INFORMATION ON THE AMOUNT OF BLOOD LOST WAS PROVIDED, AND A BLOOD TRANSFUSION WAS REQUIRED. MEDICAL INTERVENTION/TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23796730 ↗InjuryDec 12, 2025Difficult to Remove; Difficult to Remove
ACCORDING TO THE REPORTER, AFTER INSERTING THE NEEDLE INTO THE VEIN AND INSERTING THE GUIDE WIRE, THE NEEDLE GOT STUCK IN THE GUIDE WIRE AND WAS NOT REMOVED. THIS WAS OBSERVED IN BOTH OF THE TWO (2) KITS. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23796729 ↗MalfunctionOct 21, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
ACCORDING TO THE REPORTER, THE GUIDEWIRE WAS STUCK. IT WAS ALSO STATED THAT WHEN THE PHYSICIAN TRIED TO REMOVE THE GUIDEWIRE, IT BEGAN TO UNRAVEL. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 23354156 ↗InjuryOct 17, 2025Product Quality Problem; Product Quality Problem
ACCORDING TO THE REPORTER, DURING PLACEMENT, THE GUIDE WIRE WAS KINKED AND REQUIRED A CUT DOWN. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 23323295 ↗MalfunctionAug 1, 2025Difficult to Remove; Difficult to Remove
ACCORDING TO THE REPORTER, WHEN INSERTING THE GUIDEWIRE, IT GETS STUCK IN THE CATHETER. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 22690157 ↗MalfunctionJul 2, 2025Unraveled Material; Unraveled Material
ACCORDING TO THE REPORTER, DURING THE INSERTION OF THE DEVICE'S GUIDEWIRE, FRAYING OCCURRED AT THE TIP OF THE WIRE JUST AFTER PASSING THROUGH THE NEEDLE, MAKING IT IMPOSSIBLE TO ADVANCE OR RETRACT THE WIRE. AFTER SEVERAL ATTEMPTS, IT WAS POSSIBLE TO THREAD OR SUCCESSFULLY REMOVE THE GUIDE WIRE. THE FRAYED GUIDEWIRE DID NOT BREAK INTO PIECES. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. NO OTHER PRODUCTS ARE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE IS USED ON THE DEVICE. AS A REMEDIAL ACTION AND INTERVENTION, A NEW REPLACEMENT GUIDEWIRE WAS USED WITHOUT THE NEED FOR ANOTHER KIT (BY SELLING THE GUIDEWIRE ALONE), AND THIS EXTENDED THE PROCEDURE TIME. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE REMEDIAL ACTION WAS PERFORMED. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22384468 ↗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 ↗MalfunctionApr 28, 2025Unraveled Material; Premature Indicator Activation; Unraveled Material; Premature Indicator Activation
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, INSTEAD OF THE INCLUDED 18G PUNCTURE NEEDLE, ANOTHER 18G CANNULA NEEDLE WAS PREPARED AND USED TO PUNCTURE IT. HOWEVER, THE GUIDEWIRE DID NOT PASS THROUGH, SO A 16G CANNULA NEEDLE WAS USED AND THE PROCEDURE WAS CONTINUED. THE GUIDEWIRE PASSED THROUGH THE CANNULA NEEDLE, BUT IT DID NOT COME OUT ANYMORE. WHEN A SMALL AMOUNT OF FORCE WAS APPLIED TO PULL IT OUT, THE COILED GUIDEWIRE WAS DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21917755 ↗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 ↗MalfunctionNov 15, 2024Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE REPORTER, DURING THE PROCEDURE IN A VERY STRESSFUL ENVIRONMENT IN THE ICU, THE GUIDEWIRE DID NOT GO THROUGH THE TRIPLE LUMEN. SO IT WAS NOT POSSIBLE TO GET THE CATHETER OVER THE WIRE AS IT DID NOT EXIT AND WAS BLOCKED. THE ANESTHESIOLOGIST THEN CHANGED TO ANOTHER CATHETER WITH THE SAME GUIDEWIRE, AND THE NEW CATHETER WAS PLACED SUCCESSFULLY. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCT WAS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO BLOOD TRANSFUSION PERFORMED. IT WAS STATED THAT THE ACUTE PATIENT IN THE ICU DIED DUE TO OTHER CAUSES AND WAS BOTH RESPIRATORY AND CARDIAC VERY ILL.
Patient problems: Insufficient Information
MAUDE report 20694007 ↗MalfunctionNov 14, 2024Difficult to Remove; Difficult to Remove
ACCORDING TO THE REPORTER, THE WIRE WAS UNLABELED. THERE HAD NOT BEEN MANY TIMES THE WIRE HAD BEEN PUSHED BACK; THE SENSATION OF PUSHING IT SEVERAL TIMES HAD NO LONGER BEEN FELT, SO THE METAL NEEDLE HAD BEEN REMOVED. TEGO WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20685280 ↗MalfunctionOct 9, 2024Obstruction of Flow; Obstruction of Flow
ACCORDING TO THE REPORTER, WHILE THE USAGE METHODS REMAINED UNCHANGED, AN INCIDENT OCCURRED WHERE BLOOD DID NOT FLOW DURING ITS USE. USAGE WAS DISCONTINUED DUE TO SUSPICION OF CATHETER LUMEN OBSTRUCTION. THERE WAS NO LEAK. THERE WERE NO PROBLEM WITH THE LUER ADAPTER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20408126 ↗
Other Mozarc Medical US LLC products
All Mozarc Medical US LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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