NC SPRINTER® NCSP3015XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169282421), received between Dec 13, 2022 and Dec 13, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2022Burst Container or Vessel; Detachment of Device or Device Component; Device Dislodged or Dislocated; Burst Container or Vessel; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE NC SPRINTER PTCA BALLOON CATHETER TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION WITH 70% STENOSIS, IN THE DISTAL LEFT MAIN (LM) CORONARY ARTERY AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LEFT ANTERIOR DESCENDING (LAD) ARTERY HAD 70% IN-STENT RESTENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. A 3.5 NON-MEDTRONIC GUIDEWIRE WAS PLACED IN THE DISTAL LAD. THE LESION WAS PRE-DILATED WITH A 2.0 X 10MM BALLOON AND A 3.0 X 12MM SPRINTER LEGEND BALLOON UP TO 16 ATM. A 3.0 X 15MM RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED AT THE PROXIMAL LAD AT 18 ATM. THE STENT WAS BEING POST-DILATED WITH THE NC SPRINTER BALLOON AT 16 ATM. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED DURING THE BALLOON INFLATION AT 16 ATM. THE RUPTURED BALLOON WAS RETAINED IN THE LAD. AN ATTEMPT WAS MADE TO REMOVE THE RUPTURED BALLOON WITH NON-MEDTRONIC GUIDE EXTENSION CATHETERS AND A 4.0 SNARE, BUT IT WAS NOT POSSIBLE TO REMOVE. A 3.0 X 22MM RESOLUTE INTEGRITY STENT WAS USED TO ENTRAP THE REMNANT BALLOON AT THE PROXIMAL LAD AT 18 ATM. FINAL ANGIOGRAM SHOWED GOOD RESULT WITH TIMI 3 FLOW. IT WAS STATED THAT THE STENT WAS INSERTE

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 15967924 ↗