Quantum MaverickRecalls & reported problems across all models
Boston Scientific Corporation · 36 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 743
- Deaths reported
- 2
- Injuries reported
- 19
- Recalls
- 0
We found 36 models of Quantum Maverick by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 743 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2016 and Sep 18, 2026 — classified as 2 deaths, 19 injuries, 722 malfunctions.
The most frequently reported specific device problem is “Break” (316 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 Quantum Maverick problems
Device problems
- Break316
- Failure to Advance141
- Material Rupture111
- Material Deformation79
- Inflation Problem33
- Kinked23
- Adverse Event Without Identified Device or Use Problem19
- Difficult to Advance11
Patient problems
- No Consequences Or Impact To Patient537
- No Clinical Signs, Symptoms or Conditions152
- No Patient Involvement47
- No Known Impact Or Consequence To Patient15
- Low Blood Pressure/ Hypotension3
- Cardiac Tamponade2
- Death2
- Cardiogenic Shock1
Quantum Maverick models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quantum™ Maverick™ H7493808012300Catheters, transluminal coronary angioplasty, percutaneous86 reports
- Quantum™ Maverick™ H7493808015300Catheters, transluminal coronary angioplasty, percutaneous79 reports
- Quantum™ Maverick™ H7493808012350Catheters, transluminal coronary angioplasty, percutaneous69 reports
- Quantum™ Maverick™ H7493808012250Catheters, transluminal coronary angioplasty, percutaneous1 death57 reports
- Quantum™ Maverick™ H7493808015350Catheters, transluminal coronary angioplasty, percutaneous56 reports
- Quantum™ Maverick™ H7493808012270Catheters, transluminal coronary angioplasty, percutaneous1 death49 reports
- Quantum™ Maverick™ H7493808015250Catheters, transluminal coronary angioplasty, percutaneous36 reports
- Quantum™ Maverick™ H7493808008350Catheters, transluminal coronary angioplasty, percutaneous35 reports
- Quantum™ Maverick™ H7493808008300Catheters, transluminal coronary angioplasty, percutaneous34 reports
- Quantum™ Maverick™ H7493808012400Catheters, transluminal coronary angioplasty, percutaneous32 reports
- Quantum™ Maverick™ H7493808015270Catheters, transluminal coronary angioplasty, percutaneous32 reports
- Quantum™ Maverick™ H7493808008400Catheters, transluminal coronary angioplasty, percutaneous20 reports
- Quantum™ Maverick™ H7493808008270Catheters, transluminal coronary angioplasty, percutaneous17 reports
- Quantum™ Maverick™ H7493808015400Catheters, transluminal coronary angioplasty, percutaneous17 reports
- Quantum™ Maverick™ H7493808012370Catheters, transluminal coronary angioplasty, percutaneous16 reports
- Quantum™ Maverick™ H7493808015320Catheters, transluminal coronary angioplasty, percutaneous15 reports
- Quantum™ Maverick™ H7493808008250Catheters, transluminal coronary angioplasty, percutaneous11 reports
- Quantum™ Maverick™ H7493808008450Catheters, transluminal coronary angioplasty, percutaneous11 reports
- Quantum™ Maverick™ H7493808012320Catheters, transluminal coronary angioplasty, percutaneous11 reports
- Quantum™ Maverick™ H7493808015370Catheters, transluminal coronary angioplasty, percutaneous9 reports
- Quantum™ Maverick™ H7493808008320Catheters, transluminal coronary angioplasty, percutaneous7 reports
- Quantum™ Maverick™ H7493808012450Catheters, transluminal coronary angioplasty, percutaneous7 reports
- Quantum™ Maverick™ H7493808008370Catheters, transluminal coronary angioplasty, percutaneous5 reports
- Quantum™ Maverick™ H7493808012200Catheters, transluminal coronary angioplasty, percutaneous5 reports
- Quantum™ Maverick™ H7493808015450Catheters, transluminal coronary angioplasty, percutaneous5 reports
- Quantum™ Maverick™ H7493808008500Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Quantum™ Maverick™ H7493808020250Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Quantum™ Maverick™ H7493808020300Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Quantum™ Maverick™ H7493808012220Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Quantum™ Maverick™ H7493808015500Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Quantum™ Maverick™ H7493808020270Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Quantum™ Maverick™ H7493808020350Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Quantum™ Maverick™ H7493808012500Catheters, transluminal coronary angioplasty, percutaneous1 report
- Quantum™ Maverick™ H7493808015200Catheters, transluminal coronary angioplasty, percutaneous1 report
- Quantum™ Maverick™ H7493808015220Catheters, transluminal coronary angioplasty, percutaneous1 report
- Quantum™ Maverick™ H7493808020200Catheters, transluminal coronary angioplasty, percutaneous1 report
Recent Quantum Maverick adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828478 ↗MalfunctionSep 17, 2026Material Rupture; Failure to Deflate
It was reported that a balloon rupture occurred.A 3.00 mm x 12 mm Quantum Maverick was selected for use. The balloon was advanced to the target lesion and inflated once at 12 ATM for 5 to 10 seconds. During inflation, the balloon ruptured, resulting in improper deflation of the device. The device was successfully removed from the patient, and the procedure was completed with another same device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800566 ↗MalfunctionApr 2, 2026Break; Fluid/Blood Leak
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR POST DILATATION. HOWEVER, DURING INFLATION, A LEAK WITHOUT ANY VISIBLE PINHOLES WAS DETECTED AND UPON INSPECTION, THE BALLOON DELIVERY SHAFT WAS NOTED TO BE BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766872 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 12MM QUANTUM? MAVERICK? BALLOON CATHETER WAS ADVANCED FOR USED. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED. THE PATIENT STATUS WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24674472 ↗MalfunctionFeb 24, 2026Contamination; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT CONTAMINATION OCCURRED. THE 93% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 15MM QUANTUM? MAVERICK? BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, UPON UNPACKING, IT WAS NOTICED THAT THE BALLOON WAS CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS. THE PATIENT STATUS WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430540 ↗MalfunctionFeb 19, 2026Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT CORONARY STENT IMPLANTATION. THE 83% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.75MM X 15MM QUANTUM? MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCESS OF INSERTION, BALLOON DELIVERY SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24394000 ↗MalfunctionJan 27, 2026Break; Nonstandard Device
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT CORONARY ANGIOGRAPHY AND INTRACORONARY STENT IMPLANTATION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING BRANCH. A 2.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE CATHETER SHAFT FRACTURED INSIDE THE PATIENT. THE SAME GUIDE CATHETER USED FOR THE PROCEDURE WAS UTILIZED TO COMPLETELY RETRIEVE BOTH THE BALLOON AND THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24190327 ↗MalfunctionJan 4, 2026Nonstandard Device; Failure to Advance
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15DEC2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.0MM X 15MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT BALLOON HAD A LONGITUDINAL TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23954128 ↗MalfunctionJan 2, 2026Break
IT WAS REPORTED THAT A DETACHMENT OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 4.0MM X 8MM QUANTUM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, THE DEVICE WAS FRACTURED AFTER UNPACKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23946097 ↗InjuryDec 24, 2025Break; Nonstandard Device; Difficult to Advance; Break; Nonstandard Device; Difficult to Advance
IT WAS REPORTED THAT SHAFT BREAK OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PREVIOUSLY UNDERWENT DUAL STENTING ON THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE LEFT CIRCUMFLEX ARTERY (LCX). DUE TO SUSPICIONS THAT THE LCX STENT MIGHT NOT HAVE BEEN OPTIMALLY DEPLOYED AND THE PATIENT'S RECURRENT SYMPTOMS, A DECISION WAS MADE TO PROCEED WITH A REPEAT SURGICAL INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LCX. THE PHYSICIAN INITIALLY ATTEMPTED TO IMPLANT AN ADDITIONAL STENT IN THE LCX. A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS PRE-POSITIONED IN THE LAD. THE STENT WAS THREADED THROUGH A NON-BOSTON SCIENTIFIC IMPLANTED STENT IN LAD TOWARD THE LCX BUT WAS UNSUCCESSFUL. THE BALLOON WAS THEN WITHDRAWN, AND THE PHYSICIAN OPTED TO PLACE A STENT FROM THE LAD TO THE LEFT MAIN ARTERY. POST-DEPLOYMENT, A 3.0MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS USED FOR POST-DILATATION; HOWEVER, DURING ADVANCING, RESISTANCE WAS ENCOUNTERED. THE BALLOON WAS REMOVED USING A 2.0MM BALLOON TO ANCHOR THE QUANTUM MAVERICK WITHIN THE GUIDING CATHETER. UPON INSPECTION, THE DISTAL END OF THE BALLOON'S DELIVERY SHAFT WAS FOUND TO B
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23889601 ↗MalfunctionDec 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. PRIOR TO THE PROCEDURE, THE HEAD NURSE OPENED THE OUTER PACKAGE OF THE DEVICE AND NOTED THAT THE LABEL INDICATED A 4.0 X 12 MM QUANTUM? MAVERICK?. HOWEVER, THE LABEL ON THE INNER PACKAGE INDICATED A 3.0 X 12 MM QUANTUM? MAVERICK?. THE INNER PACKAGE WAS NOT OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT REMAINED STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865121 ↗MalfunctionDec 15, 2025Nonstandard Device; Failure to Advance; Nonstandard Device; Failure to Advance
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25NOV2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.5MM X 8MM FG QUANTUM MAVERICK BALLOON CATHETER T WAS ADVANCED FOR DILATATION. HOWEVER, DURING TRACKING, THE DEVICE FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE BALLOON HAD RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23809726 ↗MalfunctionDec 15, 2025Break; Difficult to Advance; Human-Device Interface Problem; Break; Difficult to Advance; Human-Device Interface Problem
IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 3.00 X 12 MM QUANTUM? MAVERICK? BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A HIGHLY RESISTANT, 90% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. WITH THE ASSISTANCE OF A GUIDE EXTENSION CATHETER, THE BALLOON WAS ADVANCED WITH SIGNIFICANT RESISTANCE TO THE AREA WHERE A PREVIOUSLY POSITIONED NON-BOSTON SCIENTIFIC SENT WAS POORLY APPOSED. AFTER SEVERAL DILATIONS, THE DELIVERY SHAFT WAS NOTED TO BE BROKEN WITHIN THE GUIDE CATHETER. ANCHORING WITH A 2.00 MM NON-COMPLIANT BALLOON WAS NECESSARY IN ORDER TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23807126 ↗MalfunctionDec 1, 2025Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.5MM X 12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, SHAFT WAS FRACTURED DURING DELIVERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23680319 ↗InjuryNov 20, 2025Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate
IT WAS REPORTED THAT DEFLATION AND REMOVAL ISSUES OCCURRED RESULTING IN ADDITIONAL INTERVENTION. THE 70 - 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, NON-CALCIFIED RIGHT CORONARY ARTERY. FOLLOW DEPLOYMENT OF A NON-BOSTON SCIENTIFIC STENT, IT WAS NOTED THAT THE STENT DID NOT FULLY ADHERE TO THE VESSEL WALL, NECESSITATING RE-EXPANSION AND FINE-TUNING. A 4.50 MM X 15 MM QUANTUM? MAVERICK? BALLOON CATHETER WAS INTRODUCED BUT COULD NOT BE WITHDRAWN. A LARGE SYRINGE AND NEW PRESSURE PUMP WERE USED TO DEFLATE AND WITHDRAW THE BALLOON. A TRANSIENT OCCURRENCE OF CARDIAC ISCHEMIA WAS ALSO REPORTED. AFTER WITHDRAWAL, THE BALLOON STILL COULD NOT BE FULLY DEFLATED OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED USING A NON-BSC POST-DILATATION BALLOON AND THE PATIENT WAS STABLE.
Patient problems: Ischemia
MAUDE report 23609420 ↗
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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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