Maverick²Recalls & reported problems across all models
Boston Scientific Corporation · 30 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 799
- Deaths reported
- 4
- Injuries reported
- 22
- Recalls
- 0
We found 30 models of Maverick² by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 799 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2016 and Sep 24, 2026 — classified as 4 deaths, 22 injuries, 773 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (422 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 Maverick² problems
Device problems
- Material Rupture422
- Break193
- Failure to Advance118
- Adverse Event Without Identified Device or Use Problem38
- Nonstandard Device36
- Material Deformation35
- Inflation Problem26
- Difficult to Advance15
Patient problems
- No Consequences Or Impact To Patient413
- No Clinical Signs, Symptoms or Conditions329
- No Patient Involvement34
- No Known Impact Or Consequence To Patient17
- Low Blood Pressure/ Hypotension6
- Cardiac Arrest4
- Foreign Body In Patient3
- Vascular Dissection3
Maverick² models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Maverick²™ H7493892815200Catheters, transluminal coronary angioplasty, percutaneous1 death203 reports
- Maverick²™ H7493892820200Catheters, transluminal coronary angioplasty, percutaneous161 reports
- Maverick²™ H7493892815250Catheters, transluminal coronary angioplasty, percutaneous111 reports
- Maverick²™ H7493892815150Catheters, transluminal coronary angioplasty, percutaneous1 death92 reports
- Maverick²™ H7493892820250Catheters, transluminal coronary angioplasty, percutaneous79 reports
- Maverick²™ H7493892820150Catheters, transluminal coronary angioplasty, percutaneous40 reports
- Maverick²™ H7493892812200Catheters, transluminal coronary angioplasty, percutaneous2 deaths37 reports
- Maverick²™ H7493892812250Catheters, transluminal coronary angioplasty, percutaneous21 reports
- Maverick²™ H7493892809200Catheters, transluminal coronary angioplasty, percutaneous14 reports
- Maverick²™ H7493892820300Catheters, transluminal coronary angioplasty, percutaneous8 reports
- Maverick²™ H7493892815300Catheters, transluminal coronary angioplasty, percutaneous7 reports
- Maverick²™ H7493892812350Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Maverick²™ H7493892809250Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Maverick²™ H7493892815270Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Maverick²™ H7493892820270Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Maverick²™ H7493892820400Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Maverick²™ H7493892830250Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Maverick® H7492062020150Catheters, transluminal coronary angioplasty, percutaneous1 report
- Maverick® H7492062009150Catheters, transluminal coronary angioplasty, percutaneous1 report
- Maverick® H7492062012200Catheters, transluminal coronary angioplasty, percutaneous1 report
- Maverick® H7492062015200Catheters, transluminal coronary angioplasty, percutaneous1 report
- Maverick® H7492062015300Catheters, transluminal coronary angioplasty, percutaneous1 report
- Maverick® H7492062015150Catheters, transluminal coronary angioplasty, percutaneous1 report
- Maverick® H7492062020350Catheters, transluminal coronary angioplasty, percutaneous1 report
- Maverick²™ H7493892809220Catheters, transluminal coronary angioplasty, percutaneous1 report
- Maverick²™ H7493892812270Catheters, transluminal coronary angioplasty, percutaneous1 report
- Maverick²™ H7493892815350Catheters, transluminal coronary angioplasty, percutaneous1 report
- Maverick²™ H7493892820350Catheters, transluminal coronary angioplasty, percutaneous1 report
- Maverick²™ H7493892825200Catheters, transluminal coronary angioplasty, percutaneous1 report
- Maverick²™ H7493892830200Catheters, transluminal coronary angioplasty, percutaneous1 report
Recent Maverick² adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Rupture
It was reported that balloon rupture occurred.The 60% target lesion was located in the moderate to severely tortuous and mildly calcified left anterior descending artery. The first 2.00mm x 20mm Maverick 2 balloon catheter was advanced for dilation. However, at 8 - 12 atmospheres, the balloon ruptured. Then, second 2.50mm x 15mm Maverick 2 balloon catheter was used to pre-dilate the left anterior descending artery lesion at 8 - 12 atmospheres, but balloon rupture was observed. The non-BSC guidewire from the third diagonal branch was exchanged to the second diagonal branch, and the 2.5mm x 15mm Maverick balloon was used to pre-dilate the second diagonal branch lesion at 8 - 12 atmospheres. An attempt to advance the 2.5mm x 10mm Wolverine cutting balloon to the lesion in the anterior descending artery was unsuccessful. The diagonal branch guidewire was withdrawn, the microcatheter was advanced past the stenotic lesion in the anterior descending artery, and a rotational atherectomy guidewire was exchanged to the distal segment of the anterior descending artery. The 1.5 BSC rotational atherectomy tip was advanced to the calcified lesions in the proximal and mid segments and rotated at
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884197 ↗DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient died.The patient presented with 95% stenosis of the left anterior descending artery (LAD) and 90% stenosis of the right coronary artery (RCA) with high calcium and tortuosity of the vessel. After the bed was prepared with a 1.50 x 15 mm Maverick 2 balloon a non-Boston Scientific (non-BSC) stent was deployed and post dilated successfully. The proximal RCA was then pre-dilated with a 2.00 x 12 mm Maverick 2 balloon and another non-BSC stent was successfully deployed and post-dilated. After deployment of the second stent in the RCA, a non-BSC drug coated balloon was used at the proximal end. After completion of the procedure, the patient was stable and sent to the coronary care unit for post-procedural monitoring. During the night, the patient developed hypotension and went into cardiac arrest. Cardiopulmonary Resuscitation was immediately started and continued. Once the pressure got done and the patient did not come back, they were declared expired. An autopsy was not performed.
Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension
MAUDE report 50800969 ↗DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient died.The patient presented with 95% stenosis of the left anterior descending artery (LAD) and 90% stenosis of the right coronary artery (RCA) with high calcium and tortuosity of the vessel. After the bed was prepared with a 1.50 x 15 mm Maverick 2 balloon a non-Boston Scientific (non-BSC) stent was deployed and post dilated successfully. The proximal RCA was then pre-dilated with a 2.00 x 12 mm Maverick 2 balloon and another non-BSC stent was successfully deployed and post-dilated. After deployment of the second stent in the RCA, a non-BSC drug coated balloon was used at the proximal end. After completion of the procedure, the patient was stable and sent to the coronary care unit for post-procedural monitoring. During the night, the patient developed hypotension and went into cardiac arrest. Cardiopulmonary Resuscitation was immediately started and continued. Once the pressure got done and the patient did not come back, they were declared expired. An autopsy was not performed.
Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension
MAUDE report 50800966 ↗MalfunctionAug 11, 2026Material Rupture
It was reported that balloon rupture occurred.A 90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal to mid right coronary artery. A 2.50mm x 15mm Maverick? balloon catheter was used for pre-dilatation at 8 to 12 atmospheres. However, during the pre-dilatation, the proximal bend first and the balloon ruptured. The procedure was completed and another device was used to complete the procedure. Intraoperative ECG and hemodynamic parameters remained stable, and the patient experienced no specific discomfort. He was returned to the ward postoperatively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214650 ↗InjuryJul 27, 2026Material Rupture
It was reported that a device issue occurred resulting in patient complications.The occluded target lesion was located in the left anterior descending artery (LAD). A non-Boston Scientific (BSC) guidewire successfully crossed the occluded segment and reached the distal vessel. A 2.50mm x 20mm Maverick balloon catheter was advanced from the proximal to the distal LAD. Repeat angiography showed no flow through the mid-segment. Pre-dilatation was then performed at 12 atmospheres. Repeat angiography demonstrated a thin thread of blood flow through the occluded segment with significant thrombus burden. There was an indication for intracoronary thrombolysis. The balloon was intentionally ruptured and advanced to the proximal end of the thrombus. A total of 20 mg of pro-urokinase was administered through the punctured balloon. Repeat angiography demonstrated reduced thrombus burden with subtotal occlusion and TIMI 1 flow in the distal segment. Significant thrombus burden remained following repeat angiography. A thrombus aspiration catheter was advanced to the proximal end of the thrombus. Continuous negative pressure aspiration was initiated while slowly advancing the catheter to the mid-
Patient problems: Foreign Body In Patient; Reduced Blood Flow; Thrombosis/Thrombus
MAUDE report 50009735 ↗MalfunctionApr 21, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION AND UNDERWENT EMERGENCY CORONARY INTERVENTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED PROXIMAL TO MIDDLE SEGMENT OF THE ANTERIOR DESCENDING BRANCH. A 2.00MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION AT 14 ATMOSPHERES FOR 10 SECONDS, THE INFLATION PRESSURE FAILED TO RISE AND THE BALLOON RUPTURED, WHICH OCCURRED WHEN SEVERE VASCULAR CALCIFICATION WAS ENCOUNTERED. SUBSEQUENTLY, A HIGH-PRESSURE BALLOON WAS USED FOR DILATATION, AND THE TREATMENT WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24941255 ↗MalfunctionMar 30, 2026Break; Nonstandard Device
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 2.50MM X 15MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCESS OF DELIVERING THE GUIDE WIRE INTO THE PATIENT'S BODY, THE DELIVERY SHAFT OF THE DEVICE FRACTURED. THE DEVICE WAS PROMPTLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729069 ↗MalfunctionMar 30, 2026Break; Difficult to Advance
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. AFTER 6F EBU 3.5 NON-BOSTON SCIENTIFIC GUIDE CATHETER WAS ENGAGED, A 2.00MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION IN AN ATTEMPT TO REACH THE LESION. HOWEVER, HALFWAY THROUGH THE PROCEDURE, THE SHAFT OF THE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) BALLOON DILATATION CATHETER FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 24720029 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED ON A 70% STENOSED TARGET LESION LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS USED TO ENGAGE THE VESSEL, AND A 2.00MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHILE ADVANCING THE BALLOON THROUGH THE NON-BSC GUIDE CATHETER, THE BALLOON CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 24636781 ↗MalfunctionMar 13, 2026Nonstandard Device; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON RUPTURED DUE TO SEVERAL CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. PATIENT WAS IN GOOD CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24595854 ↗MalfunctionMar 8, 2026Nonstandard Device; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION, A 2.00MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST DUE TO SEVERE CALCIFICATION. THE BALLON WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24542036 ↗MalfunctionMar 4, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM X 15MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST DUE TO SEVERE CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24508054 ↗MalfunctionMar 3, 2026Material Separation
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 2.00MM X 15MM MAVERICK BALLOON CATHETER WAS SELECTED FOR USE. DURING PREPARATION INSPECTION IT WAS NOTED THAT THE CATHETER TIP WAS FRACTURED. THE DEVICE WAS REPLACED AND THE PROCEDURE PROCEEDED SMOOTHLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24502253 ↗MalfunctionMar 3, 2026Nonstandard Device; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.00MM X 15MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500672 ↗MalfunctionMar 3, 2026Nonstandard Device; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM X 15MM MAVERICK? BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED POST PROCEDURE, AND THE PATIENT CONDITION WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498127 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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