ApexRecalls & 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
- 82
- Deaths reported
- 2
- Injuries reported
- 10
- Recalls
- 0
We found 30 models of Apex by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Nov 10, 2023 — classified as 2 deaths, 10 injuries, 70 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (29 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 Apex problems
Device problems
- Material Rupture29
- Break13
- Adverse Event Without Identified Device or Use Problem7
- Hole In Material5
- Difficult to Remove4
- Entrapment of Device4
- Leak/Splash4
- Deflation Problem2
Patient problems
- No Consequences Or Impact To Patient46
- No Clinical Signs, Symptoms or Conditions18
- No Patient Involvement9
- Perforation of Vessels3
- Cardiogenic Shock2
- Death2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Apex models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Apex™ H7493895912200Catheters, transluminal coronary angioplasty, percutaneous12 reports
- Apex™ H7493895912250Catheters, transluminal coronary angioplasty, percutaneous9 reports
- Apex™ H7493895915250Catheters, transluminal coronary angioplasty, percutaneous7 reports
- Apex™ H7493895920250Catheters, transluminal coronary angioplasty, percutaneous6 reports
- Apex™ H7493895915320Catheters, transluminal coronary angioplasty, percutaneous5 reports
- Apex™ H7493895915200Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Apex™ H7493895920300Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Apex™ H7493895940200Catheters, transluminal coronary angioplasty, percutaneous1 death4 reports
- Apex™ H7493895808200Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Apex™ H7493895808250Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Apex™ H7493895915300Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Apex™ H7493895915500Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Apex™ H7493895930200Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Apex™ H7493895940250Catheters, transluminal coronary angioplasty, percutaneous1 death2 reports
- Apex™ H7493895812250Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895815250Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895908200Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895908250Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895908400Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895912300Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895915220Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895915350Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895920200Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895920350Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895920400Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895930250Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895930300Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895940300Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895940350Catheters, transluminal coronary angioplasty, percutaneous1 report
- Apex™ H7493895940400Catheters, transluminal coronary angioplasty, percutaneous1 report
Recent Apex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2023Break; Break
IT WAS REPORTED VIA USER MEDWATCH (B)(4) THAT SHAFT BREAK OCCURRED. A 2.50MM X 12MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN REMOVING THE BALLOON OVER THE GUIDEWIRE, THE BALLOON DELIVERY SYSTEM BROKE AT THE RX PORT ON THE SHAFT. THE CATHETER AND THE WIRE WERE REMOVED AS ONE UNIT, AND THE DISTAL END OF THE BALLOON CATHETER WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18110179 ↗MalfunctionNov 7, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 3.00MM X 20MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED AND LEFT A STAIN IN THE ARTERY. THE DEVICE WAS REMOVED, AND ANOTHER 3.00MM X 20MM APEX BALLOON CATHETER WAS ADVANCED, BUT THE BALLOON ALSO RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH AN NC QUANTUM BALLOON, AND IMPLANTATION OF A SYNERGY XD DRUG-ELUTING STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18083126 ↗MalfunctionNov 6, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 3.00MM X 20MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED AND LEFT A STAIN IN THE ARTERY. THE DEVICE WAS REMOVED, AND ANOTHER 3.00MM X 20MM APEX BALLOON CATHETER WAS ADVANCED, BUT THE BALLOON ALSO RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH AN NC QUANTUM BALLOON, AND IMPLANTATION OF A SYNERGY XD DRUG-ELUTING STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18076532 ↗MalfunctionOct 31, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE. THE 2.00 MM X 30 MM APEX MR BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE THE BALLOON DID NOT INFLATE AND WAS FILLED WITH BLOOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18039210 ↗InjuryJan 20, 2023Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. A 3.00MM X 20MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING REMOVAL OF THE BALLOON, THE SHAFT OF THE BALLOON FRACTURED. THE PHYSICIAN SNARED THE REST OF THE BALLOON OUT OF THE GUIDE CATHETER. ALL ITEMS WERE REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16216352 ↗MalfunctionSep 30, 2022Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED VIA MAUDE REPORT MW5111784 THAT SHAFT BREAK OCCURRED. A 2.00MM X 12MM APEX BALLOON CATHETER WAS ADVANCED FOR USE. THE APEX BALLOON CATHETER WAS INSERTED. A KINKED WAS OBSERVED AND THE APEX BALLOON CATHETER BROKE WHEN IT WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510957 ↗MalfunctionSep 27, 2022Material Rupture; Material Rupture
IT WAS REPORTED VIA USER FACILITY OR VOLUNTARY MEDWATCH #: (B)(4) THAT BALLOON RUPTURE OCCURRED. PERCUTANEOUS INTERVENTION, STENT PLACEMENT AND BALLOON ANGIOPLASTY WERE PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. TWO 3.25MM X 15MM APEX BALLOON CATHETERS WERE ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE AT NOMINAL PRESSURE, BOTH BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15493610 ↗MalfunctionSep 27, 2022Material Rupture; Material Rupture
IT WAS REPORTED VIA USER FACILITY OR VOLUNTARY MEDWATCH #: (B)(4) THAT BALLOON RUPTURE OCCURRED. PERCUTANEOUS INTERVENTION, STENT PLACEMENT AND BALLOON ANGIOPLASTY WERE PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. TWO 3.25MM X 15MM APEX BALLOON CATHETERS WERE ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE AT NOMINAL PRESSURE, BOTH BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15491410 ↗MalfunctionSep 24, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.25MM X 15MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 11 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15481284 ↗MalfunctionSep 24, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.25MM X 15MM APEX BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 11 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15480301 ↗MalfunctionSep 21, 2022Material Rupture
EARLY 70¿S FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE. PROCEDURE: PERCUTANEOUS INTERVENTION, STENT PLACEMENT AND BALLOON ANGIOPLASTY IN THE PROXIMAL RIGHT CORONARY. BALLOON RUPTURED @ NOMINAL, 2 DEVICES- 2 ATTEMPTS. 3RD ONE WORKED WELL. NO KNOWN HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, APEX¿ (PER SITE REPORTER). WILL OBTAIN. MANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, APEX¿ (PER SITE REPORTER). WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15461630 ↗MalfunctionAug 5, 2022Material Twisted/Bent
UPPER 70¿S MALE WITH HISTORY OF HYPERTENSION AND RECENT CHEST PAIN. PROCEDURE: LEFT HEART CATH AND STENT TO LEFT ANTERIOR DESCENDING (LAD). WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, THE BALLOON WAS BENT. NOT USED ON PATIENT. NEW DEVICE OBTAINED WITHOUT COMPLICATIONS. MANUFACTURER RESPONSE FOR CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS, APEX¿ (PER SITE REPORTER). WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15174213 ↗MalfunctionJul 28, 2022Material Twisted/Bent
EARLY 80¿S MALE WITH DIABETES AND RECENT CHEST PAIN. PROCEDURE; PERCUTANEOUS INTERVENTION PROXIMAL RIGHT CORONARY, STENT PLACEMENT AND BALLOON ANGIOPLASTY. BALLOON SHAFT KINKED AND NOT ABLE TO USE FOR PROCEDURE. REMOVED AND USED ANOTHER DEVICE WITHOUT COMPLICATIONS. NO KNOWN HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15120946 ↗MalfunctionJul 12, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 15MM APEX BALLOON WAS SELECTED FOR USE. DURING PREPARATION, THE BALLOON RUPTURED WHEN NEGATIVE WAS PULLED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5 X 15 BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14996285 ↗MalfunctionJun 5, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A STENT DISLODGED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A TORTUOUS CIRCUMFLEX (CX). A GUIDEZILLA, A 3.00MM X 40MM APEX BALLOON, AND A 4.50 X 32MM SYNERGY MEGATRON STENT WERE SELECTED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON, AND THE BALLOON WAS NOTED TO BE SHEARED. THE DEVICES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14599683 ↗
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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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