NIRxcell CoCr Coronary Stent on RX System NXL27533USRecalls & 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 07290107010856), received between Jul 19, 2016 and Jul 19, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Angina1
- Myocardial Infarction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2016Insufficient Device Problem Information
IT WAS REPORTED ON (B)(6) 2016 (LATE EVENING) BY (B)(6), CLINICAL SPECIALIST I (B)(6) THAT A POST PROCEDURE EVENT OCCURRED ON (B)(6) 2016 TO PATIENT FROM (B)(6) STUDY. THE EVENT OCCURRED AT (B)(6) USA. THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2016 WITH NIRXCELL CORONARY STENT SYSTEM, CATALOG # NXL27533US, TYPE 2.75X33, FROM LOT # NUS00166 AND IT WAS REPORTED THAT, " EVENT TERM: NON-ST ELEVATION MYOCARDIAL INFARCTION". "DESCRIPTION: SUBJECT PRESENTED WITH ANGINA. SERIAL TROPONINS DRAWN AND THEY WERE ELEVATED SLIGHTLY. SHE WAS ADMITTED. SUB - I DISCHARGED HER ON MEDICATION THERAPY. TROPONIN ELEVATION THOUGHT TO BE FROM PROCEDURE". INFORMATION RECEIVED ON (B)(6) 2016 THROUGH (B)(6), CLINICAL SPECIALIST I FROM (B)(6) ((B)(4) AND DATA CENTER): ((B)(4) NOTIFICATION). SITE NUMBER: (B)(6). SITE NAME: (B)(6). SUBJECT NUMBER: (B)(6). EVENT SEQUENCE NUMBER: 1. EVENT TERM: NON-ST ELEVATION MYOCARDIAL INFARCTION. START DATE: (B)(6) 2016. RELATED TO THE DEVICE (AS REPORTED): POSSIBLY RELATED. RELATED TO THE PROCEDURE (AS REPORTED): POSSIBLY RELATED. THERE WAS NO SERIOUS CONGENITAL ANOMALY OR BIRTH DEFECT, NO SIGNIFICANT DISABILITY AND NO DEATH. SERIOUS CRITERIA: HOSPITALIZATION: YES; LIFE THR
Patient problems: Angina; Myocardial Infarction
MAUDE report 5805034 ↗
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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