NC SPRINTER® NCSP3527XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169282032), received between Jan 2, 2025 and Jan 2, 2025 — classified as 1 malfunction.

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.

• MalfunctionJan 2, 2025Burst Container or Vessel; Entrapment of Device; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn; Burst Container or Vessel; Entrapment of Device; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN NC SPRINTER BALLOON CATHETER, A LESION STENOSIS OF 90% WAS IDENTIFIED IN THE PROXIMAL SECTION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ARTERY HAD MILD TORTUOSITY AND MODERATE CALCIFICATION. THE BALLOON BURST DURING BALLOON INFLATION AT 18 ATMS ON THE SECOND INFLATION. THE BALLOON WRAPPED AND TORE. THE LESION WAS PRE-DILATED, AND NONRESISTANCE OR EXCESSIVE FORCE WAS ENCOUNTERED DURING THE DEVICE'S ADVANCEMENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITHOUT ISSUES. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053211 ↗