NIRxcell CoCr Coronary Stent on RX System NXL35028USRecalls & 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 07290107010986), received between Apr 9, 2017 and Apr 9, 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
Patient problems
- No Consequences Or Impact To Patient1
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE STENT CAME OFF THE STENT DELIVERY BALLOON IN THE GUIDE CATHETER AS THE DOCTOR WAS RETRIEVING IT FROM THE OSTIAL RCA BECAUSE IT WOULDN'T CROSS. WHEN HE PULLED THE SDS ALL THE WAY OUT HE NOTICED THE STENT WASN'T ON THE BALLOON. HE THEN USED FLUORO AND DETERMINED THE STENT WAS IN THE GUIDE CATHETER AT WHICH TIME HE HAD TO PULL THE GUIDE AND WIRE OUT OF THE PATIENT. DE NOVO, 85% STENOSIS, NO BIFURCATION, NO PRE EXISTING CLOT. THERE WAS NO PRE DILATION. LESION CALCIFICATION: MEDIUM. VESSEL CALCIFICATION: LOW. VESSEL WAS NOT TORTUOUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE AND APPEARED NORMAL. THE SYSTEM WAS STORED, HANDLED AND PREPPED ACCORDING TO THE IFU. THE GUIDING CATHETER AND STENT DELIVERY SYSTEM WERE NOT REMOVED AS A SINGLE UNIT. THE DELIVERY SYSTEM WAS REMOVED BY RETRACTING IT INTO THE GUIDING CATHETER.
Patient problems: No Consequences Or Impact To Patient; Stenosis
MAUDE report 6474625 ↗
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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