NC SPRINTER® NCSP3012XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169282414), received between Feb 24, 2025 and Sep 16, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Deflation Problem; Entrapment of Device; Difficult to Remove; Deflation Problem; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC SPRINTER RX CORONARY BALLOON CATHETER, BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED AND THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. IT WAS BELIEVED THAT THE DEVICE TOOK A LITTLE EXTRA EFFORT TO REMOVE THROUGH THE GUIDE CATHETER. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066540 ↗
• InjuryJun 6, 2025Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  DURING A PROCEDURE INVOLVING THE NC SPRINTER RX BALLOON, IT WAS REPORTED THAT THE DEVICE DID NOT FULLY INFLATE, RESULTING IN A DISSECTION AND BALLOON DEFORMATION. INFLATION EXTENDED BEYOND THE TWO MARKER BANDS. THE LESION WAS LOCATED IN THE MID LAD ARTERY, WITH MILD CALCIFICATION AND NO TORTUOSITY. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED, BOTH WITH NO ISSUES IDENTIFIED. NO RESISTANCE OR EXCESSIVE FORCE WAS ENCOUNTERED DURING DELIVERY. THE LESION WAS NOT PRE-DILATED AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic dissection; Vascular Dissection

  MAUDE report 22160824 ↗
• MalfunctionFeb 24, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC SPRINTER RX CORONARY BALLOON CATHETER, BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED AND THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE BALLOON FAILED TO DEFLATE. IT WAS MANAGED TO MANUALLY 'WIGGLE' AND DEFLATE THE BALLOON. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445417 ↗