NIRxcell CoCr Coronary Stent on RX System NXL30033USRecalls & reported problems
Medinol Ltd. · Class 3 · Implant
All models of NIRxcell CoCr Coronary Stent on RX System (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290107010924), received between Feb 24, 2016 and Feb 24, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Unraveled Material1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2016Unraveled Material; Device Dislodged or Dislocated
EVENT OCCURRED DURING POST MARKET CLINICAL STUDY, (B)(6). (B)(4). DATE OF INDEX PROCEDURE: (B)(6) 2016. TIME TO EVENT (DAYS): 0 DAYS. THIS REPORT IS FOR SUBJECT (B)(4), AN (B)(6) FEMALE PARTICIPATING IN THE (B)(6) STUDY. THE STUDY IS A "PROSPECTIVE, POST-MARKETING, NONRANDOMIZED, MULTI-CENTER, SINGLE-ARM CLINICAL STUDY. THIS STUDY IS DESIGNED TO COLLECT AND ANALYZE ADDITIONAL INFORMATION ABOUT THE SAFETY AND EFFECTIVENESS OF THE NIRXCELL STENT SYSTEM IN THE TREATMENT OF DE NOVO STENOTIC LESIONS IN NATIVE CORONARY ARTERIES IN THE US POPULATION". THE SUBJECT'S RELEVANT MEDICAL HISTORY INCLUDES PREVIOUS PERCUTANEOUS CORONARY INTERVENTION IN 2012, FAMILY HISTORY OF PREMATURE CORONARY ARTERY, ATRIAL FIBRILLATION, DIABETES MELLITUS, HYPERTENSION AND HYPERCHOLESTEROLEMIA. THE SUBJECT'S CONCOMITANT MEDICATIONS INCLUDE: HEPARIN, NITROGLYCERIN, ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2016, THE SUBJECT UNDERWENT THE INDEX PROCEDURE WITH UNSUCCESSFUL DEPLOYMENT NIRXCELL STENT IN THE MIDDLE RCA. AFTER PRE-DILATATION THE STUDY STENT WAS UNABLE TO CROSS THE TARGET LESION AND WHILE ATTEMPTING TO PULL IT BACK INTO THE GUIDE, THE STUDY STENT DID NOT PULL BACK AND IT WAS DISLODGED FROM THE DELIVERY SYSTEM
Patient problems: No Code Available
MAUDE report 5456019 ↗
Other Stent, Coronary devices
- WALLSTENT® Endoprosthesis H965403130Boston Scientific Corporation · STENT, CORONARY35 reports
- WALLSTENT® Endoprosthesis H965402130Boston Scientific Corporation · STENT, CORONARY23 reports
- Tryton Side Branch Stent T5-2530-191-USTryton Medical, Inc. · Stent, Coronary1 death22 reports
- WALLSTENT® Endoprosthesis H965403330Boston Scientific Corporation · STENT, CORONARY21 reports
- WALLSTENT® Endoprosthesis H965403320Boston Scientific Corporation · STENT, CORONARY10 reports
- WALLSTENT® Endoprosthesis H965403120Boston Scientific Corporation · STENT, CORONARY9 reports
- Tryton Side Branch Stent T5-3035-151-USTryton Medical, Inc. · Stent, Coronary2 deaths7 reports
- MULTI-LINK VISION 1007850-15Abbott Vascular Inc. · STENT, CORONARY7 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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