NC SPRINTER® NCSP37515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169282070), received between Feb 23, 2026 and Feb 23, 2026 — 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.

• InjuryFeb 23, 2026Burst Container or Vessel; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC SPRINTER RX BALLOON CATHETER, THE BALLOON BURST DURING BALLOON INFLATION AT 20ATM, EXCEEDING THE RATED BURST PRESSURE (RBP) OF 18 ATM. THE TARGET LESION WAS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY WHICH EXHIBITED NO TORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE WAS NOT INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE PROXIMAL CIRCUMFLEX LESION WAS PRE-DILATED WITH A 2.5MM NON-COMPLIANT (NC) BALLOON, FOLLOWED BY A 3.0MM NC BALLOON, FOLLOWED BY A 3.5 MM SHOCKWAVE BALLOON. A GUIDELINER WAS THEN USED TO DELIVER A 3.5 X 26 RESOLUTE INTEGRITY STENT. POST-IMPLANT OF THE STENT, A 4.5 MM NC BALLOON WAS USED TO DILATE THE DISTAL AND MID SECTION OF THE STENT. THE 3.75 X 15 NC SPRINTER BALLOON WAS SMOOTHLY DELIVERED TO THE PROXIMAL END OF THE STENT THROUGH THE GUIDELINER AND INFLATED TO 20 ATM. THE BALLOON RUPTURED. THE BALLOON CATHETER WAS WITHDRAWN FRO

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

  MAUDE report 24412986 ↗