NIRxcell CoCr Coronary Stent on RX System NXL27517USRecalls & 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 07290107010818), received between Nov 29, 2016 and Nov 29, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Bent” (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
- Bent1
- Device Dislodged or Dislocated1
- Material Deformation1
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.
MalfunctionNov 29, 2016Bent; Device Dislodged or Dislocated; Material Deformation; Bent; Device Dislodged or Dislocated; Material Deformation
EVENT DESCRIPTION: PER (B)(6), THE CATH LAB SUPERVISOR IN (B)(6). DURING LHC TURNED INTO PCI, AFTER PREDILATING LESION A NEW 2.75 X 17 NIRXCELL STENT WAS OPENED. THE DEVICE WAS PROPERLY HANDLED AND THE PHYSICIAN (B)(6) DELIVERED THE DEVICE. IT WAS NOTED THAT THERE WAS NO STENT IN THE VESSEL. THE STENT WAS LOCATED ON THE SCRUB TABLE. IT NEVER ENTERED THE BODY. DR. (B)(6) PROPERLY HANDLED THE STENT. THE TEAM ALSO PROPERLY HANDLED THE STENT TO DR (B)(6). THE LOCATION OF LESION IS LHC/PCI. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON NOV 24, 2016: DURING INSPECTION PRIOR TO USE NOTHING APPEARED ABNORMAL, EXCEPT THE PHYSICIAN DID NOT NOTICE THAT THE STENT WAS NOT ON THE BALLOON, HE SAID HE WILL CHECK THIS MORE CAREFULLY IN THE FUTURE, HE ASSUMES NOW THAT MAYBE THE STENT WAS NOT CRIMPED PROPERLY ONTO THE DELIVERY SYSTEM. THE PRODUCT WAS PREPPED ACCORDING TO IFU. THERE WERE NO PROBLEM DURING PREPARATION. THERE WAS NO RESISTANCE EXPERIENCED WHILE TRACKING THE STENT DEPLOYMENT SYSTEM TO THE LESION NOR WHEN CROSSING THE LESION. UPON VISUALIZATION IN THE PATIENT ANATOMY IT WAS NOTICED THAT THERE WAS NO STENT VISIBLE SO THE STAFF BEGAN SEARCHING FOR THE STENT AND FO
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6131738 ↗
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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