NC Quantum ApexRecalls & reported problems across all models
Boston Scientific Corporation · 48 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 267
- Deaths reported
- 6
- Injuries reported
- 23
- Recalls
- 0
We found 48 models of NC Quantum Apex by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 267 adverse event reports in the FDA's MAUDE database, received between Jan 10, 2017 and Sep 21, 2026 — classified as 6 deaths, 23 injuries, 238 malfunctions.
The most frequently reported specific device problem is “Break” (89 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
Reports received per month, all models
Most reported NC Quantum Apex problems
Device problems
- Break89
- Material Rupture84
- Adverse Event Without Identified Device or Use Problem29
- Failure to Advance19
- Entrapment of Device15
- Difficult to Remove10
- Inflation Problem10
- Material Integrity Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions131
- No Consequences Or Impact To Patient87
- No Known Impact Or Consequence To Patient20
- No Patient Involvement15
- Vascular Dissection6
- Death5
- Insufficient Information4
- Air Embolism2
NC Quantum Apex models
48 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NC Quantum Apex™ H7493912412250Catheters, transluminal coronary angioplasty, percutaneous24 reports
- NC Quantum Apex™ H7493912412300Catheters, transluminal coronary angioplasty, percutaneous18 reports
- NC Quantum Apex™ H7493912415300Catheters, transluminal coronary angioplasty, percutaneous18 reports
- NC Quantum Apex™ H7493912412350Catheters, transluminal coronary angioplasty, percutaneous1 death16 reports
- NC Quantum Apex™ H7493912420250Catheters, transluminal coronary angioplasty, percutaneous12 reports
- NC Quantum Apex™ H7493912412270Catheters, transluminal coronary angioplasty, percutaneous11 reports
- NC Quantum Apex™ H7493912415250Catheters, transluminal coronary angioplasty, percutaneous11 reports
- NC Quantum Apex™ H7493912420300Catheters, transluminal coronary angioplasty, percutaneous11 reports
- NC Quantum Apex™ H7493912408300Catheters, transluminal coronary angioplasty, percutaneous1 death10 reports
- NC Quantum Apex™ H7493912408350Catheters, transluminal coronary angioplasty, percutaneous1 death10 reports
- NC Quantum Apex™ H7493912415350Catheters, transluminal coronary angioplasty, percutaneous1 death10 reports
- NC Quantum Apex™ H7493912420350Catheters, transluminal coronary angioplasty, percutaneous10 reports
- NC Quantum Apex™ H7493912415270Catheters, transluminal coronary angioplasty, percutaneous8 reports
- NC Quantum Apex™ H7493912420270Catheters, transluminal coronary angioplasty, percutaneous7 reports
- NC Quantum Apex™ H7493912412220Catheters, transluminal coronary angioplasty, percutaneous6 reports
- NC Quantum Apex™ H7493912415320Catheters, transluminal coronary angioplasty, percutaneous6 reports
- NC Quantum Apex™ H7493912408250Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Quantum Apex™ H7493912408270Catheters, transluminal coronary angioplasty, percutaneous2 deaths5 reports
- NC Quantum Apex™ H7493912412400Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Quantum Apex™ H7493912412450Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Quantum Apex™ H7493912430250Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC Quantum Apex™ H7493912415400Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC Quantum Apex™ H7493912420320Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC Quantum Apex™ H7493912430220Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC Quantum Apex™ H7493912408400Catheters, transluminal coronary angioplasty, percutaneous3 reports
- NC Quantum Apex™ H7493912420400Catheters, transluminal coronary angioplasty, percutaneous3 reports
- NC Quantum Apex™ H7493912430270Catheters, transluminal coronary angioplasty, percutaneous3 reports
- NC Quantum Apex™ H7493912406250Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Quantum Apex™ H7493912408450Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Quantum Apex™ H7493912412200Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Quantum Apex™ H7493912412320Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Quantum Apex™ H7493912415200Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Quantum Apex™ H7493912415370Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Quantum Apex™ H7493912415450Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Quantum Apex™ H7493912415500Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Quantum Apex™ H7493912420220Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Quantum Apex™ H7493912420370Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Quantum Apex™ H7493912430300Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Quantum Apex™ H7493912430350Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC Quantum Apex™ H7493912406270Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Quantum Apex™ H7493912408320Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Quantum Apex™ H7493912408370Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Quantum Apex™ H7493912408500Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Quantum Apex™ H7493912415220Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Quantum Apex™ H7493912420200Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Quantum Apex™ H7493912420500Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Quantum Apex™ H7493912430200Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC Quantum Apex™ H7493912430320Catheters, transluminal coronary angioplasty, percutaneous1 report
Recent NC Quantum Apex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848192 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847257 ↗InjurySep 21, 2026Break
It was reported shaft break occurred requiring additional intervention.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal right coronary artery. A 12mm x 3.50mm NC Quantum Apex? balloon catheter was selected for use. However, during the attempts to cross the lesion, it was noticed that the shaft was broken into two pieces. The device was completely removed using snare. The procedure was completed with another 12mm x 3.50mm NC Quantum Apex MR balloon catheter. No further complications were reported, and the patient status was stable post-procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50844363 ↗MalfunctionMay 26, 2026Nonstandard Device; Failure to Advance
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-MAY-2026. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. AFTER 2.00MM AND 2.25 MM NC QUANTUM APEX BALLOON CATHETERS CROSSED THE LESION, A 8MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER FAILED TO CROSS. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT RUPTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25293223 ↗MalfunctionMay 7, 2026Break; Nonstandard Device
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS UNDERGOING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ENGAGED COAXIALLY AND A NON-BSC GUIDEWIRE WAS CROSSED THE LESION, PRE-DILATION WAS PERFORMED WITH 2.50 X 15MM SEMI COMPLIANT BALLOON CATHETER. A 3.00 X 32MM SYNERGY SHIELD DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED. POST-DEPLOYMENT, AN 8MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, WHILE LOADING ON WIRE, THE SHAFT WAS BROKEN. ANOTHER 3.50MM X 8MM NC BALLOON CATHETER WAS USED TO POST-DILATE THE LESION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116438 ↗MalfunctionMar 4, 2026Material Puncture/Hole
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 12 X 2.50 MM NC QUANTUM APEX MR BALLOON CATHETER WAS SELECTED FOR USE. WHILE A WIRE WAS BEING ADVANCED THROUGH THE BALLOON, A HOLE BETWEEN THE IN AND EXIT PORT WAS OBSERVED, THROUGH WHICH THE GUIDEWIRE WAS EXITING. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506115 ↗MalfunctionFeb 5, 2026Inflation Problem; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN NC QUANTUM APEX 15 X 4.00MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. IT WAS DISCOVERED THAT THE BALLOON COULD NOT BE INFLATED AS THE BALLOON HAD ALREADY BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272249 ↗MalfunctionFeb 5, 2026Nonstandard Device; Material Separation
IT WAS REPORTED THAT A DETACHMENT OCCURRED. AN NC QUANTUM APEX MR 2.75 X 20MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. WHEN REMOVING THE BALLOON FROM THE PROTECTOR, THE PHYSICIAN NOTED THAT THE BALLOON WAS CUT. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272187 ↗MalfunctionDec 9, 2025Nonstandard Device; Failure to Advance; Nonstandard Device; Failure to Advance
REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 24NOV2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AN 8MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. BUT THE DEVICE FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON LONGITUDINAL TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23758669 ↗MalfunctionNov 14, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22-OCT-2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. AN 8MM X 3.00MM NC QUANTUM APEX BALLOON WAS SELECTED FOR USE. HOWEVER, IT DID NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23554969 ↗MalfunctionNov 11, 2025Nonstandard Device; Failure to Advance; Nonstandard Device; Failure to Advance
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22-OCT-2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A SMALLER SIZE OF NON-COMPLIANT BALLOON, AND AN 8MM X 4.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN LONGITUDINAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23519978 ↗MalfunctionNov 7, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). AN 8MM X 3.50MM NC QUANTUM APEX MR WAS ADVANCED FOR PRE-DILATION BUT FAILED TO CROSS THE ANGULATED LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER SMALLER SIZED BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE BALLOON TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498291 ↗MalfunctionOct 26, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AFTER A NON-BSC GUIDEWIRE CROSSED THE LESION, PRE-DILATATION WAS PERFORMED WITH A 12MM X 2.50MM NC QUANTUM APEX? BALLOON CATHETER. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50 X 15 MM NC QUANTUM APEX BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23387944 ↗MalfunctionSep 8, 2025Nonstandard Device; Material Rupture; Nonstandard Device; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH DOUBLE VESSEL DISEASE AND UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE CHRONIC TOTALLY OCCLUDED TARGET LESIONS WERE LOCATED IN THE RIGHT CORONARY ARTERY (RCA) AND LEFT MAIN TO LEFT ANTERIOR DESCENDING ARTERY (LMLAD). AFTER SUCCESSFUL RCA INTERVENTION, PTCA TO LMLAD WAS PERFORMED UNDER INTRAVASCULAR ULTRASOUND (IVUS) GUIDANCE BY INSERTING 7F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER. THE LESION WAS CROSSED WITH A NON-BSC GUIDEWIRE, AND IVUS EVALUATION WAS DONE FOLLOWED BY STENTING IN THE LMLAD. AN 8MM X 4.50MM NC QUANTUM APEX? BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, ON THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22998437 ↗InjuryAug 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY HEART DISEASE. A 12 X 3.00 MM NC QUANTUM APEX WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). NO DAMAGE WAS OBSERVED DURING UNPACKING OR PREPARATION, AND THE DEVICE ADVANCED SMOOTHLY OVER THE WIRE AND GUIDEWIRE. DURING THE PROCEDURE, THE BALLOON TIP DETACHED FROM THE CATHETER. IT WAS SUCCESSFULLY RETRIEVED BY USING A SECOND BALLOON TO EXTRACT IT FROM THE PATIENT. THE PROCEDURE SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT COMPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22864692 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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