NIRxcell CoCr Coronary Stent on RX System NXL25012USRecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290107010764), received between Apr 9, 2017 and Apr 9, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Difficult to Advance1
- Improper or Incorrect Procedure or Method1
- Kinked1
Patient problems
- Aneurysm1
- Myocardial Infarction1
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2017Break; Kinked; Improper or Incorrect Procedure or Method; Difficult to Advance; Break; Kinked; Improper or Incorrect Procedure or Method; Difficult to Advance
REPORTABILITY WAS DECIDED ON MARCH 28, 2017 AFTER RE-REVIEWING THE EVENT FILE. STEMI PATIENT THAT ALSO HAD AN ABDOMINAL AORTIC ANEURYSM WITH MULTIPLE LESIONS IN LAD AND OM1; PHYSICIAN AND STAFF IN THE CASE NOTED EXTREMELY TORTUOUS ANATOMY ESPECIALLY AT THE SITE OF THE UNTREATED LESION, MID OM1; THERE WAS AN EXTREMELY TIGHT TORTUOUS LOOP IN THE OM1 WHERE THE NIRXCELL 2.5 X 12 WAS UNABLE TO TRACK TO DESPITE THE USE OF A GUIDELINER, MULTIPLE PRE DILATIONS, AND DEPLOYMENT OF A 2.5 X 17 IN THE PROXIMAL OM1; PHYSICIAN APPLIED ENOUGH PUSH ON THE SDS OF THE NIRXCELL 2.5 X 12 THAT THE CATHETER KINKED AND EVENTUALLY SNAPPED; THE PATIENT WAS NOT HARMED DURING THE PROCEDURE; ULTIMATELY NO STENTS WERE ABLE TO TRACK TO THIS LESION IN THE MID OM1; THE PHYSICIAN WAS ABLE TO SUCCESSFULLY TREAT A TIGHT LESION IN THE LAD WITH A 3.0 X 17 NIRXCELL AND A DIFFERENT LESION IN THE PROXIMAL OM1 WITH A 2.5 X 17 NIRXCELL. THE DEVICE WAS USED IN ACUTE MI. DE NOVO, STENOSIS 95%, NO BIFURCATION, NO PRE EXISTING CLOT. THERE WAS PREDILATION WITH PRESSURE 12. STENT DILATION PRESSURE WAS 18. THERE WAS POST DILATION WITH PRESSURE 20. TIMI FLOW PRE PROCEDURE WAS 2 AND TIMI FLOW POST PROCEDURE WAS 3. TWO STENTS WERE DE
Patient problems: Aneurysm; Myocardial Infarction; Stenosis
MAUDE report 6474624 ↗
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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