NIRxcell CoCr Coronary Stent on RX System NXL40017USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107011020), received between Nov 23, 2015 and Jan 4, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INITIAL INFORMATION: TRIED TO PLACE STENT IN RCA WHEN IT CAME OFF THE SYSTEM. THEY CRUSHED THE STENT WITH A BALLOON AND THEN PLACED AN ABBOTT VISION STENT TO COVER THE CRUSHED STENT. PATIENT IS CURRENTLY IN STABLE CONDITION. ADDITIONAL INFORMATION RECEIVED DEC 14 2016: DOCTOR WAS TRYING TO DELIVER THE STENT TO THE LESION. STENT WASN'T ABLE TO CROSS LESION AND ENDED UP COMING OFF THE DELIVERY SYSTEM. THEY TRIED TO RETRIEVE WITH SNARE BUT WAS UNABLE TO. SO THEY CRUSHED THE STENT WITH A BALLOON AND THEN PLACED AN ABBOTT VISION OVER THE CRUSHED STENT. THE PHYSICIAN WAS TRAINED WITH THE PROCEDURE. VISUAL INSPECTION WAS PERFORMED PRIOR TO USE, AND THE STENT WAS HANDLED PROPERLY AND USED ACCORDING TO THE IFU. THE DOCTOR DID NOT NOTICE DAMAGE TO THE SYSTEM PRIOR TO USE. THE VESSEL WAS CALCIFIED BUT WAS NOT TORTURES. PRE DILATATION WAS NOT PERFORMED. FOLLOWING THE PROCEDURE THE SYSTEM WAS INSPECTED AND WAS FOUND TO BE UNDAMAGED. THE CONDITION OF THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient; Vessel Or Plaque, Device Embedded In

  MAUDE report 6220807 ↗
• MalfunctionNov 23, 2015Device Dislodged or Dislocated

  MEDINOL RECEIVED A COMPLAINT ((B)(4)) COVERING TWO EVENTS. THE FIRST EVENT OCCURRED PRIOR TO USE AND IS CONSIDERED AS NON-REPORTABLE. THE SECOND EVENT OCCURRED DURING THE PROCEDURE AND WAS ASSESSED AS REPORTABLE. DESCRIPTION OF THE FIRST, NON-REPORTABLE EVENT: UPON REMOVING THE STENT DELIVERY SYSTEM (PART NUMBER: NXL40017US, LOT NUMBER: NUS00047) FROM THE STERILE PACKAGE, THE PHYSICIAN NOTICED THE STENT WAS MOVING ON THE BALLOON AND WAS NOT FIRMLY SURROUNDING THE BALLOON. THE SYSTEM WAS NOT USED. THE PHYSICIAN DECIDED TO USE ANOTHER STENT (PART NUMBER: NXL40017US, LOT NUMBER: NUS00206). DESCRIPTION OF THE SECOND, REPORTABLE EVENT: THE PHYSICIAN ADVANCED WITH THE PROCEDURE AND THE SECOND STENT WAS INSERTED INTO THE PATIENT. AS THE LESION WAS BEING CROSSED, THE PHYSICIAN NOTICED THAT THE STENT HAD PARTIALLY DISLODGED FROM THE BALLOON. THE PHYSICIAN WAS ABLE TO REPOSITION THE BALLOON UNDERNEATH THE STENT AND THEN WAS ABLE TO DEPLOY THE BALLOON AFTER THE STENT WAS REPOSITIONED. PROCEDURE WAS COMPLETED; PATIENT'S CONDITION WAS GOOD.

  Patient problems: No Information

  MAUDE report 5270459 ↗