NIRxcell CoCr Coronary Stent on RX System NXL40012USRecalls & 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 07290107011013), received between Jun 5, 2017 and Jun 5, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Dislodged or Dislocated1
- Difficult to Remove1
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.
MalfunctionJun 5, 2017Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated
INITIAL INFORMATION: THE TECH HAD DIFFICULTY GETTING THE STYLET OFF THE SYSTEM. ONCE HE TOOK THE STYLET OFF, HE INSPECTED THE SYSTEM AND SAW THAT THE STENT WAS PARTIALLY DISLODGED FROM THE BALLOON. THIS WAS INFORMATION GIVEN BY ANOTHER PARTY. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION ON MAY 18, 2017: NIRXCELL WAS HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. BOTH THE DOCTOR AND THE TECH TRIED TO REMOVE THE SHIPPING MANDREL STATING THAT THE METAL EYE WAS UNDER THE PLASTIC AND IT WAS VERY DIFFICULT TO REMOVE. THE STENT WAS NOT MANIPULATED AFTER REMOVING THE PROTECTIVE SLEEVE WITH SHIPPING MANDREL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6610446 ↗
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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