NIRxcell CoCr Coronary Stent on RX System NXL30020USRecalls & 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 07290107010894), received between Jan 4, 2017 and Jan 4, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Issue” (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 Issue1
Patient problems
- Pain1
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 4, 2017Device Issue; Device Issue
DESCRIPTION: I RECEIVED AN EMAIL FROM DR. (B)(6) THAT STATING "WE RECENTLY HAD 2 ACUTE STENT THROMBOSIS WITH MEDINOL. I CALLED (B)(6) TO DISCUSS AS HE IS THE PRIMARY USER OF NIRXCELL AT THIS ACCOUNT. HE SAID HE WAS GOING TO LOOK THE PATIENTS UP NEXT WEEK AND LET ME KNOW THE DETAILS." THIS COMPLAINT WAS INITIALLY RECEIVED AND FILED AS (B)(4) ON (B)(6) 2016. LATE EVENING ON (B)(6) 2016 MEDINOL RECEIVED EMAIL FROM MEDINOL USA CONFIRMING THAT THIS COMPLAINT INVOLVED TWO DIFFERENT PATIENTS. AS A RESULTS MEDINOL OPENS THIS COMPLAINT (B)(4) FOR THE SECOND INCIDENT. ADDITIONAL INFORMATION RECEIVED DEC 20 2016: ON (B)(6) 2016 A FEMALE WITH NON STEMI ANGINA WAS SCHEDULED FOR A HEART CATH WITH DR. (B)(6). IT WAS DISCOVERED SHE HAD A NATIVE CIRCUMFLEX LESION THAT WAS TREATED WITH A 3.0X20 NIRXCELL (NO LOT # AVAILABLE). ON (B)(6) 2016 SHE PRESENTED TO THE ER WITH BACK AND CHEST PAIN AND DR. (B)(6) DISCOVERED A PROXIMAL EDGE STENOSIS OF THE NIRXCELL IN WHICH HE PLACED A XIENCE STENT WHICH OVERLAPPED THE NIRXCELL. DR. (B)(6), DR. (B)(6) AND MYSELF ALL AGREED IT WAS EDGE RESTENOSIS NOT AN ST. COMPLAINT CLASSIFICATION WAS CHANGED FROM STENT THROMBOSIS TO IN-STENT RESTENOSIS.
Patient problems: Pain; Stenosis
MAUDE report 6220806 ↗
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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