NIRxcell CoCr Coronary Stent on RX System NXL30012USRecalls & 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 07290107010870), received between Apr 27, 2017 and Apr 27, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
Patient problems
- Myocardial Infarction1
- Stenosis1
- Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2017Failure to Advance; Failure to Advance
(B)(6) MALE PATIENT WHO IS ACTIVE DRUG USER (HEROIN) HAD HIGH RISK BIFURCATION LESION AT MID LAD AND 2ND DIAGONAL BRANCH; ONE 3.0 X 17 NIRXCELL WAS SUCCESSFULLY DEPLOYED AT MID LAD. HOWEVER, PLAQUE SHIFTED DISTALLY CREATING THE NEED FOR A SECOND STENT PLACEMENT. AT THAT TIME, A SECOND NIRXCELL SIZE 3.0 X 12 WAS SELECTED TO BE PLACED DISTAL TO THE 3.0 X 17 BUT WAS UNABLE TO RECROSS THE JUST DEPLOYED 3.0 X17. THE PHYSICIAN PULLED OUT THE 3.0 X 12 NIRXCELL AND WAS ABLE TO SUCCESSFULLY DEPLOY A 3.0 X 12 STENT FROM OTHER COMPANY WHICH DID RECROSS THE JUST DEPLOYED 3.0 X 17 NIRXCELL. PROCEDURE WAS THEN COMPLETED WITH OTHER COMPANY'S STENT SIZE 2.5 X18 DEPLOYED IN THE 2ND DIAGONAL. STAFF NOTED THAT THEY HAD DIFFICULTY KEEPING PATIENT STILL WHICH RESULTED IN PATIENT LOSING HIS IV AND REPEATED ATTEMPTS TO INTRODUCE HEPARIN WERE UNSUCCESSFUL AS A RESULT THEY WERE UNABLE TO GET ACT TO TARGET. THE LOST IV WAS NOTICED AT COMPLETION OF CASE AS A PUDDLE OF HEPARIN SOLUTION WAS FOUND ON THE FLOOR. PER THE RN AND RT IN THE CASE, THIS LIKELY LED TO THE THROMBUS THAT OCCURRED DURING THE PROCEDURE WHILE TRYING TO DELIVER THE 2ND NIRXCELL STENT (3.0 X 12). PATIENT'S BLOOD WAS IN A HYPERCOAGUABLE STATE
Patient problems: Myocardial Infarction; Stenosis; Thrombus
MAUDE report 6525274 ↗
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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