NIRxcell CoCr Coronary Stent on RX System NXL40008USRecalls & 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 07290107011006), received between Apr 9, 2017 and Apr 9, 2017 — classified as 1 injury.
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
- Vessel Or Plaque, Device Embedded In1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE NIRXCELL STENT DISLODGED FROM THE DELIVERY SYSTEM WAS REPORTED. NIRXCELL INFLATED TO 6 ATM AND THEN A "WATERMELON SEED" EFFECT WAS NOTICED IN WHICH STENT MOVED TOWARD/INTO AORTA. DURING THE NEXT PICTURE, THE STENT WAS NOT SEEN. ENTIRE SYSTEM (GUIDE CATHETER, GUIDE WIRE, STENT DELIVERY SYSTEM) WAS REMOVED FROM PATIENT. EVENTUALLY STENT WAS FOUND UNDER FLOURO IN PATIENTS SFA. THE DOCTOR WAS ABLE TO INFLATE A DIFFERENT BALLOON IN THE SFA TO CRUSH THE NIRXCELL INTO THE VESSEL WALL, AS STENT WAS NOT ABLE TO BE RETRIEVED/REMOVED. STENT HAD BECOME LODGED BECAUSE PATIENT HAD A CHRONIC TOTAL OCCLUSION IN THE SFA. CTO WAS FIXED DURING VASCULAR SURGEON'S PROCEDURE. THE LESION WAS PROXIMAL RCA NEAR OSTIUM. PATIENT IS CURRENTLY STABLE. THE NIRXCELL STENT SYSTEM APPEARED NORMAL DURING INSPECTION PRIOR TO USE. THE SYSTEM WAS PREPPED ACCORDING TO THE IFU. THE DOCTOR DID NOT NOTICE ANY PROBLEM OF STENT RETENTION ON THE BALLOON. NO EXTENSIVE FORCE WAS USED DURING PROCEDURE. THERE WAS NO INJURY TO PATIENT.
Patient problems: Vessel Or Plaque, Device Embedded In
MAUDE report 6474617 ↗
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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