NIRxcell CoCr Coronary Stent on RX System NXL27520USRecalls & 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 07290107010825), 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
- Angina1
- 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
INITIAL INFORMATION: AN EMAIL WAS RECEIVED FROM DR. (B)(6) STATING "WE RECENTLY HAD 2 ACUTE STENT THROMBOSIS WITH MEDINOL. I CALLED (B)(6) MD 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." ADDITIONAL INFORMATION WAS RECEIVED FROM MEDINOL USA ON DECEMBER 12, 2016: IT WAS CONFIRMED THAT THE COMPLAINT WAS ABOUT 2 PATIENTS AND THEREFORE MEDINOL DECIDED TO OPEN TWO SEPARATE COMPLAINTS WITH THE CURRENT INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED FROM MEDINOL USA ON DECEMBER 20, 2016: IT WAS CONFIRMED THAT THE COMPLAINT WAS ABOUT 3 PATIENTS AND THEREFORE MEDINOL OPENED THE THIRD COMPLAINT. ADDITIONAL INFORMATION WAS RECEIVED FROM MEDINOL USA ON DECEMBER 21, 2016: "ON (B)(6) 2016, A MALE CAME IN (B)(6) WITH AN OCCLUDED MID RCA. HE RECEIVED A NIRXCELL 2.75X20 (NO LOT AVAILABLE) THAT WAS PRE-DILATED WITH A 2.5X20MM TREK AND POST-DILATED WITH 3.0X20MM TREK. HE WAS SENT HOME ON BRILINTA WITH 1 MONTH FREE SCRIPT, HE CALLED THE OFFICE AFTER FIRST MONTH TO SAY THAT HE COULD NOT AFFORD TO PURCHASE IT THE NEXT MONTH. HE WAS SWITCHED TO PLAVIX. ON (B)(6) 2016, HE REPRESENTED TO THE E.R. WITH
Patient problems: Angina; Stenosis
MAUDE report 6220804 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page