NC SPRINTER® NCSP2021XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169282223), received between Apr 8, 2022 and Apr 8, 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 16, 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.

• InjuryApr 8, 2022Burst Container or Vessel; Burst Container or Vessel

  ONE NC SPRINTER RX BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING THE FIRST BALLOON INFLATION. IT WAS STATED THAT 10 ATM OF PRESSURE WAS APPLIED BUT THE BALLOON DID NOT INFLATE. IT WAS ALSO STATED THAT THE BURST CAUSED CONTRAST TO GO DOWN THE VESSEL AND THE PHYSICIAN HAD WORK TO GET FLOW AGAIN. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14051280 ↗