NC SPRINTERRecalls & reported problems across all models

We found 13 models of NC SPRINTER by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Mar 9, 2020 and Feb 23, 2026 — classified as 6 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported NC SPRINTER problems

NC SPRINTER models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NC SPRINTER® NCSP2515X

  Catheters, transluminal coronary angioplasty, percutaneous
  4 reports
• NC SPRINTER® NCSP27512X

  Catheters, transluminal coronary angioplasty, percutaneous
  3 reports
• NC SPRINTER® NCSP3012X

  Catheters, transluminal coronary angioplasty, percutaneous
  3 reports
• NC SPRINTER® NCSP3027X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• NC SPRINTER® NCSP3512X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• NC SPRINTER® NCSP3515X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• NC SPRINTER® NCSP3527X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• NC SPRINTER® NCSP37515X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• NC SPRINTER® NCSP5015X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• NC SPRINTER® NCSP2021X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• NC SPRINTER® NCSP2521X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• NC SPRINTER® NCSP27515X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• NC SPRINTER® NCSP3015X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report

Recent NC SPRINTER adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 16, 2024Difficult to Open or Remove Packaging Material; Material Deformation; Material Split, Cut or Torn; Difficult to Open or Remove Packaging Material; Material Deformation; Material Split, Cut or Torn

  IT WAS INTENDED TO USE ONE NC SPRINTER CORONARY BALLOON CATHETER DURING A PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THE STYLET WAS DIFFICULT TO REMOVE. THERE WAS RESISTANCE IN REMOVING THE STYLET. IT WAS ULTIMATELY REMOVED RESULTING IN STRETCHING THE CATHETER. THE STYLET CAUSED A TEAR IN THE PHYSICIAN'S GLOVE. NO ATTEMPT WAS MADE TO LOAD THE BALLOON ONTO THE GUIDEWIRE. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19998444 ↗
• MalfunctionJul 22, 2024Difficult to Open or Remove Packaging Material; Material Deformation; Material Split, Cut or Torn; Difficult to Open or Remove Packaging Material; Material Deformation; Material Split, Cut or Torn

  IT WAS INTENDED TO USE ONE NC SPRINTER CORONARY BALLOON CATHETER DURING A PROCEDURE. THERE WERE ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS REPORTED THAT THE INNER STYLET WAS DIFFICULT TO REMOVE. DURING THE REMOVAL ATTEMPT THE INNER STYLET POKED THROUGH THE USER'S GLOVE. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791617 ↗
• MalfunctionJul 4, 2024Deflation Problem; Inflation Problem; Difficult to Remove; Material Deformation; Deflation Problem; Inflation Problem; Difficult to Remove; Material Deformation

  AN ATTEMPT WAS MADE TO USE AN NC SPRINTER CORONARY BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT 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. THE DEVICE WAS BEING USED TO POST-DILATE A DEPLOYED STENT. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED. THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS ALSO REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED FOLLOWING BALLOON INFLATION. THE BALLOON WAS MOVED PROXIMALLY FROM THE STENT, AND THEN GENTLY REMOVED FROM THE STENT WITHOUT IMPACTING THE STENT PLACEMENT. THE BALLOON WAS THEN SNUGGED UP TO THE DISTAL END OF THE LAUNCHER GUIDE CATHETER AND THE ENTIRE SYSTEM WAS REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19673839 ↗
• MalfunctionApr 25, 2024Burst Container or Vessel; Leak/Splash; Material Deformation; Burst Container or Vessel; Leak/Splash; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE NC SPRINTER CORONARY BALLOON CATHETER. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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. IT WAS REPORTED THAT A BALLOON BURST, OR LEAK OCCURRED DURING BALLOON INFLATION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180508 ↗
• InjuryJan 31, 2024Deflation Problem; Deflation Problem

  AN ATTEMPT WAS MADE TO USE AN NC SPRINTER CORONARY BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 80% STENOSIS IN THE MID OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES. 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. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED. THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE INFLATED BALLOON WAS PULLED OUT OF THE ARTERY. THE BALLOON WAS EVENTUALLY DEFLATED BY PUTTING POSITIVE PRESSURE USING HEPARINIZED SALINE AND THEN DEFLATING THE BALLOON. THE PATIENT ALSO HAD A DISTAL PERFORATION CAUSED BY A NON-MEDTRONIC PTCA WIRE DURING THE PROCEDURE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18612276 ↗
• InjuryDec 13, 2022Burst Container or Vessel; Detachment of Device or Device Component; Device Dislodged or Dislocated; Burst Container or Vessel; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE NC SPRINTER PTCA BALLOON CATHETER TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION WITH 70% STENOSIS, IN THE DISTAL LEFT MAIN (LM) CORONARY ARTERY AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LEFT ANTERIOR DESCENDING (LAD) ARTERY HAD 70% IN-STENT RESTENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. A 3.5 NON-MEDTRONIC GUIDEWIRE WAS PLACED IN THE DISTAL LAD. THE LESION WAS PRE-DILATED WITH A 2.0 X 10MM BALLOON AND A 3.0 X 12MM SPRINTER LEGEND BALLOON UP TO 16 ATM. A 3.0 X 15MM RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED AT THE PROXIMAL LAD AT 18 ATM. THE STENT WAS BEING POST-DILATED WITH THE NC SPRINTER BALLOON AT 16 ATM. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED DURING THE BALLOON INFLATION AT 16 ATM. THE RUPTURED BALLOON WAS RETAINED IN THE LAD. AN ATTEMPT WAS MADE TO REMOVE THE RUPTURED BALLOON WITH NON-MEDTRONIC GUIDE EXTENSION CATHETERS AND A 4.0 SNARE, BUT IT WAS NOT POSSIBLE TO REMOVE. A 3.0 X 22MM RESOLUTE INTEGRITY STENT WAS USED TO ENTRAP THE REMNANT BALLOON AT THE PROXIMAL LAD AT 18 ATM. FINAL ANGIOGRAM SHOWED GOOD RESULT WITH TIMI 3 FLOW. IT WAS STATED THAT THE STENT WAS INSERTE

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

  MAUDE report 15967924 ↗

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