NC SPRINTER® NCSP27512XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169282360), received between Mar 9, 2020 and Apr 3, 2025 — classified as 3 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.

• MalfunctionApr 3, 2025Deflation Problem; Inflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Inflation Problem; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC SPRINTER BALLOON CATHETER THERE WERE BALLOON DEFLATION DIFFICULTIES, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE FOLLOWING THE FIRST INFLATION. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP ARATION WAS PERFORMED WITH NO ISSUES. 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 BALLOON WAS SLOWLY MOVED OUT OF THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761454 ↗
• MalfunctionSep 30, 2024Deflation Problem; Difficult to Open or Remove Packaging Material; Positioning Problem; Deflation Problem; Difficult to Open or Remove Packaging Material; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE NC SPRINTER CORONARY BALLOON CATHETER TO TREAT A NON-TORTUOUS, MILDLY CALCIFIED LESION WITH 99% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS UNABLE TO CROSS. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 20332946 ↗
• MalfunctionMar 9, 2020Fracture; Fracture

  DURING A PROCEDURE A NC SPRINTER RX PTCA BALLOON CATHETER WAS INTENDED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR ANY ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUES. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED AND A CRACK WAS NOTED ON THE CLEAR PLASTIC LUER OF THE DEVICE WHEN ATTEMPTING TO INFLATE THE BALLOON. IT WAS ALSO REPORTED THAT THE LUER WAS LEAKING OUT THE SIDE. IT WAS STATED THAT NO INFLATION WAS POSSIBLE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9804573 ↗