NIRxcell CoCr Coronary Stent on RX System NXL25017USRecalls & 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 07290107010771), received between Apr 4, 2018 and Apr 4, 2018 — classified as 1 malfunction.
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
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2018Device Issue; Device Issue
THE PHYSICIAN HAD PASSED THE NIRXCELL STENT PAST A PROXIMAL / MID RCA LESION THAT THE XIENCE STENT WOULD NOT PASS. UPON PASSING THE LESION THE PHYSICIAN BEGAN THE INFLATION OF THE NIRXCELL STENT AND QUICKLY NOTICED THAT BLOOD WAS FILLING UP THE ENDOFLATER. THE PHYSICIAN IMMEDIATELY STOPPED AS IT WAS APPARENT THAT THE BALLOON THE STENT WAS CRIMPED TO WAS DEFECTIVE OR SOMETHING AND HE REMOVED THE NIRXCELL. UPON REMOVAL HE NOTICED THAT THE NIRXCELL STENT WAS SCRUNCHED ALL THE WAY TO THE DISTAL END. HE THEN OPENED 3 MORE NIRXCELL STENTS WITH NO ISSUES AND FINISHED THE CASE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7395280 ↗
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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