NC SPRINTER® NCSP2515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169282315), received between Mar 13, 2020 and Apr 28, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Burst Container or Vessel; Improper or Incorrect Procedure or Method; Burst Container or Vessel; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC SPRINTER BALLOON CATHETER, A BALLOON BURST OCCURRED DURING BALLOON INFLATION AT 15 ATMS. THE LESION WAS SEVERELY TORTUOUS, SEVERELY CALCIFIED WITH 90% STENOSIS IN THE MID TO PROXIMAL RIGHT CORONARY ARTERY (RCA). 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916613 ↗
• InjuryNov 8, 2024Burst Container or Vessel; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Burst Container or Vessel; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE AN NC SPRINTER CORONARY BALLOON CATHETER TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION WITH 40-50% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THERE WERE ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP/TRAY. 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 DURING SUBSEQUENT INFLATION. THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS ALSO REPORTED THAT THERE WERE REMOVAL DIFFICULTIES. IT WAS DETAILED THAT A 6F GUIDE CATHETER WAS ENGAGED TO THE RCA. A 0.014 NON-MEDTRONIC WIRE WAS UNABLE TO PASS THE LESION, BUT A DIFFERENT 0.014 NON-MEDTRONIC WIRE SUCCESSFULLY CROSSED THE POSTEROLATERAL BRANCH (PLB) LESION. PRE-DILATATION OF THE PLB WAS PERFORMED USING A 2.0X15MM NON-MEDTRONIC BALLOON AT 12 ATM. RESIDUAL STENOSIS OF THE PLB WAS STENTED WITH A 2.25X38MM NON-MEDTRONIC STENT AT 14 ATM. STENT POST-DILATION WAS BEING PERFORMED USING THE 2.5X15MM NC SPRINTER BALLOON UP

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

  MAUDE report 20640450 ↗
• MalfunctionMar 13, 2020Fracture; Fracture

  DURING A PROCEDURE TWO NC SPRINTER RX PTCA BALLOON CATHETERS WERE INTENDED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF EITHER DEVICE. THERE WAS NO ISSUES NOTED WHEN REMOVING THE FIRST NC SPRINTER DEVICE FROM THE HOOP. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE LUERS OF BOTH NC SPRINTERS WERE NOT INSPECTED PRIOR TO ATTACHING TO THE NON MEDTRONIC INFLATION DEVICE. NO DIFFICULTIES WERE NOTED WHEN ATTACHING THE LUERS OF BOTH NC SPRINTERS DIRECTLY TO THE INFLATION DEVICE. IT WAS REPORTED THAT BOTH BALLOONS WERE FOUND TO BE LEAKING AT THE LUER. THE CRACK WAS NOT NOTED PRIOR TO ATTACHING THE LUER OF BOTH NC SPRINTER DEVICES TO THE INFLATION DEVICE. THE LEAK WAS NOTICED WHEN TRYING TO INFLATE THE BALLOON WHILE IN THE PATIENT. NEITHER BALLOON WOULD INFLATE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9828683 ↗
• MalfunctionMar 13, 2020Fracture; Fracture

  DURING A PROCEDURE TWO NC SPRINTER RX PTCA BALLOON CATHETERS WERE INTENDED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF EITHER DEVICE. THERE WAS NO ISSUES NOTED WHEN REMOVING THE FIRST NC SPRINTER DEVICE FROM THE HOOP. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE LUERS OF BOTH NC SPRINTERS WERE NOT INSPECTED PRIOR TO ATTACHING TO THE NON MEDTRONIC INFLATION DEVICE. NO DIFFICULTIES WERE NOTED WHEN ATTACHING THE LUERS OF BOTH NC SPRINTERS DIRECTLY TO THE INFLATION DEVICE. IT WAS REPORTED THAT BOTH BALLOONS WERE FOUND TO BE LEAKING AT THE LUER. THE CRACK WAS NOT NOTED PRIOR TO ATTACHING THE LUER OF BOTH NC SPRINTER DEVICES TO THE INFLATION DEVICE. THE LEAK WAS NOTICED WHEN TRYING TO INFLATE THE BALLOON WHILE IN THE PATIENT. NEITHER BALLOON WOULD INFLATE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9828664 ↗