ChargerRecalls & reported problems across all models
Boston Scientific Corporation · 49 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 186
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 49 models of Charger by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 186 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2018 and Sep 21, 2026 — classified as 18 injuries, 168 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (144 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 Charger problems
Device problems
- Material Rupture144
- Difficult to Remove14
- Detachment of Device or Device Component10
- Inflation Problem9
- Leak/Splash9
- Break7
- Entrapment of Device6
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions97
- No Consequences Or Impact To Patient74
- No Known Impact Or Consequence To Patient5
- No Patient Involvement4
- No Code Available3
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- Embolism1
Charger models
49 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Charger™ H74939206120870CATHETER, BILIARY, DIAGNOSTIC23 reports
- Charger™ H74939206100470CATHETER, BILIARY, DIAGNOSTIC14 reports
- Charger™ H74939206100870CATHETER, BILIARY, DIAGNOSTIC10 reports
- Charger™ H74939206062010Catheter, angioplasty, peripheral, transluminal10 reports
- Charger™ H74939206080470CATHETER, BILIARY, DIAGNOSTIC10 reports
- Charger™ H74939206120470CATHETER, BILIARY, DIAGNOSTIC9 reports
- Charger™ H74939206070470CATHETER, BILIARY, DIAGNOSTIC8 reports
- Charger™ H74939206061510Catheter, angioplasty, peripheral, transluminal7 reports
- Charger™ H74939206120670Catheter, angioplasty, peripheral, transluminal6 reports
- Charger™ H74939206052010CATHETER, BILIARY, DIAGNOSTIC5 reports
- Charger™ H74939206061010CATHETER, BILIARY, DIAGNOSTIC5 reports
- Charger™ H74939206070670CATHETER, BILIARY, DIAGNOSTIC5 reports
- Charger™ H74939206080410CATHETER, BILIARY, DIAGNOSTIC5 reports
- Charger™ H74939206080670CATHETER, BILIARY, DIAGNOSTIC5 reports
- Charger™ H74939206080870Catheter, angioplasty, peripheral, transluminal5 reports
- Charger™ H74939206060810CATHETER, BILIARY, DIAGNOSTIC4 reports
- Charger™ H74939206072010Catheter, angioplasty, peripheral, transluminal4 reports
- Charger™ H74939206080810CATHETER, BILIARY, DIAGNOSTIC4 reports
- Charger™ H74939206051010CATHETER, BILIARY, DIAGNOSTIC3 reports
- Charger™ H74939206050410Catheter, angioplasty, peripheral, transluminal3 reports
- Charger™ H74939206070410CATHETER, BILIARY, DIAGNOSTIC3 reports
- Charger™ H74939206082010CATHETER, BILIARY, DIAGNOSTIC3 reports
- Charger™ H74939206100670CATHETER, BILIARY, DIAGNOSTIC2 reports
- Charger™ H74939206041510Catheter, angioplasty, peripheral, transluminal2 reports
- Charger™ H74939206060210CATHETER, BILIARY, DIAGNOSTIC2 reports
- Charger™ H74939206071010CATHETER, BILIARY, DIAGNOSTIC2 reports
- Charger™ H74939206071510Catheter, angioplasty, peripheral, transluminal2 reports
- Charger™ H74939206081010Catheter, angioplasty, peripheral, transluminal2 reports
- Charger™ H74939206090210Catheter, angioplasty, peripheral, transluminal2 reports
- Charger™ H74939206090670CATHETER, BILIARY, DIAGNOSTIC2 reports
- Charger™ H74939206100270CATHETER, BILIARY, DIAGNOSTIC1 report
- Charger™ H74939206100410CATHETER, BILIARY, DIAGNOSTIC1 report
- Charger™ H74939206031010CATHETER, BILIARY, DIAGNOSTIC1 report
- Charger™ H74939206041010CATHETER, BILIARY, DIAGNOSTIC1 report
- Charger™ H74939206041810Catheter, angioplasty, peripheral, transluminal1 report
- Charger™ H74939206040410Catheter, angioplasty, peripheral, transluminal1 report
- Charger™ H74939206040470Catheter, angioplasty, peripheral, transluminal1 report
- Charger™ H74939206040810Catheter, angioplasty, peripheral, transluminal1 report
- Charger™ H74939206051510CATHETER, BILIARY, DIAGNOSTIC1 report
- Charger™ H74939206050470CATHETER, BILIARY, DIAGNOSTIC1 report
- Charger™ H74939206061070CATHETER, BILIARY, DIAGNOSTIC1 report
- Charger™ H74939206061210CATHETER, BILIARY, DIAGNOSTIC1 report
- Charger™ H74939206060270Catheter, angioplasty, peripheral, transluminal1 report
- Charger™ H74939206060410CATHETER, BILIARY, DIAGNOSTIC1 report
- Charger™ H74939206060470CATHETER, BILIARY, DIAGNOSTIC1 report
- Charger™ H74939206090470Catheter, angioplasty, peripheral, transluminal1 report
- Charger™ H74939206040610Catheter, angioplasty, peripheral, transluminal1 report
- Charger™ H74939206060610Catheter, angioplasty, peripheral, transluminal1 report
- Charger™ H74939206070610Catheter, angioplasty, peripheral, transluminal1 report
Recent Charger adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Difficult to Remove; Failure to Deflate
It was reported that the balloon could not be withdrawn requiring additional intervention.A 10.0 x80, 75cm Charger balloon catheter was advanced for dilatation. During the venous balloon dilatation procedure, the first inflation was completed successfully. However, during the second inflation attempt, the balloon could not be withdrawn. Attempts to advance the device further were also unsuccessful. The balloon was pulled back along the vessel to the sheath entry site. The device was then removed through the sheath, and a needle was used to puncture the balloon to facilitate complete extraction. The procedure was completed with another of same device. There were no patient complications as a result of this event. The patient was stable post procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841702 ↗MalfunctionSep 17, 2026Difficult to Remove; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810489 ↗MalfunctionFeb 2, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR UNDER GENERAL ANESTHESIA. VASCULAR ACCESS WAS OBTAINED UNDER B-ULTRASOUND GUIDANCE, AND AN 8.0 X 40, 135 CM CHARGER BALLOON CATHETER WAS ADVANCED TO PERFORM THE FENESTRATION PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED BEFORE THE RATED BURST PRESSURE WAS REACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24240859 ↗MalfunctionDec 10, 2025Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT THE DEVICE BECAME ENTRAPPED ON THE GUIDEWIRE. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS USED DURING THE PROCEDURE. AN 8.0 X 40 MM, 75 CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON CATHETER AND GUIDEWIRE BECAME STUCK TOGETHER AND COULD NOT BE WITHDRAWN. AS A RESULT, THE BALLOON CATHETER AND GUIDEWIRE HAD TO BE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23773450 ↗MalfunctionNov 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. AN 8.0 X40, 135CM CHARGER WAS SELECTED FOR USE IN ANGIOPLASTY. HOWEVER, DURING INFLATION, IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23622840 ↗MalfunctionNov 17, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 8.0 X 80, 135 CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS RESULTING FROM THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569392 ↗MalfunctionNov 17, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS, MODERATELY CALCIFIED BRACHIAL ARTERY. A 7.0 X 40 MM, 75 CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AND LEAKED FLUID. THE RUPTURE POINT WAS NOTED AT APPROXIMATELY 2 CM. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23566794 ↗MalfunctionSep 26, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS FOUND THAT THE BALLOON RUPTURED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23154093 ↗MalfunctionAug 28, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS ARTIFICIAL ARTERIOVENOUS FISTULA BALLOON DILATATION IN THE LEFT FOREARM AND INTRAVENOUS THROMBOLYSIS IN THE UPPER LIMB UNDER LOCAL ANESTHESIA WITH B-ULTRASOUND POSITIONING. A 7.0 X40, 75CM CHARGER BALLOON WAS PUNCTURED SUCCESSFULLY UNDER THE GUIDANCE OF B ULTRASOUND. HOWEVER, BALLOON BURST BEFORE REACHING THE BURSTING PRESSURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AFTER THE PRESSURE PUMP RELEASED PRESSURE DURING THE FIRST INFLATION AT 12 ATMOSPHERES FOR 15 SECONDS. DEVICE EVALUATED BY MFR: THE CHARGER DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON WAS NOT FOLDED WHICH INDICATES THAT THE BALLOON WAS SUBJECTED TO POSITIVE PRESSURE. A LONGITUDINAL TEAR WAS IDENTIFIED IN THE BALLOON MATERIAL. THE TEAR MEASURED 35MM IN LENGTH AND EXTENDED FROM A POSITION 9MM DISTAL OF THE PROXIMAL MARKERBAND TO 6MM DISTAL OF THE DISTAL M
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22914031 ↗MalfunctionAug 20, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 8.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS RUPTURED DURING FIRST INFLATION AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22854188 ↗MalfunctionAug 6, 2025Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT UPPER LIMB. A 4.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS PRESSURIZED TO 20 ATMOSPHERES AND THE PRESSURE WAS REMOVED. THE BALLOON CONTINUED TO ENTER AND WAS INFLATED. IT WAS OBSERVED THAT THE PRESSURE PUMP VALUE DID NOT RISE, AND THE CONTRAST MEDIUM FLOWED BACK WITH THE BLOOD FLOW. THE BALLOON WAS JUDGED TO BE RUPTURED, THE BALLOON WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22733844 ↗MalfunctionJun 2, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE ECCENTRIC, NON-TORTUOUS AND MODERATELY CALCIFIED COMMON FEMORAL ARTERY. A 8.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR CLAUDICATION PROCEDURE. HOWEVER, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 6 ATMOSPHERES FOR <20 SECONDS. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A SMALLER 7X40 CHARGER BALLOON. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22124784 ↗MalfunctionMar 27, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A 10.0 X40, 75CM CHARGER WAS USED FOR DILATION. DURING THE PROCEDURE, A SUCCESSFUL ANGIOGRAPHY WITH A 6 FRENCH SHEATH, WAS PERFORMED AND THE LESION WAS CROSSED WITH A WIRE. IVUS WAS ALSO SUCCESSFULLY PERFORMED. HOWEVER, THERE WAS A LEAK AT THE BALLOON PACKAGE OPENING, PREVENTING BALLOON DILATION. THE BALLOON RUPTURED ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21707557 ↗MalfunctionMar 25, 2025Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture
IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS SITUATED IN THE PERIPHERAL ARTERY. A 10.0 X 40 MM, 75 CM CHARGER BALLOON CATHETER WAS SELECTED FOR DILATION. THE PROCEDURE COMMENCED WITH A SUCCESSFUL ANGIOGRAPHY PERFORMED VIA A 6 FRENCH SHEATH, AND THE LESION WAS SUCCESSFULLY CROSSED WITH A GUIDEWIRE. ADDITIONALLY, INTRAVASCULAR ULTRASOUND (IVUS) WAS EFFECTIVELY CONDUCTED TO FURTHER ASSESS THE LESION. HOWEVER, DURING THE PREPARATION FOR BALLOON DILATION, A LEAK WAS DETECTED AT THE BALLOON PACKAGE OPENING. THIS ISSUE LED TO THE BALLOON RUPTURING UPON THE FIRST INFLATION ATTEMPT. CONSEQUENTLY, THE PLANNED DILATION COULD NOT BE COMPLETED WITH THE INITIAL DEVICE. THE PROCEDURE WAS SUBSEQUENTLY ADAPTED, AND AN ALTERNATIVE DEVICE WAS UTILIZED TO ACHIEVE THE DESIRED OUTCOME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21688544 ↗MalfunctionMar 6, 2025Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 17FEB2025. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS ILIAC VEIN. A 8.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION.DURING THE PROCEDURE, THE PRESSURE PUMP WAS UTILIZED TO INFLATE THE DEVICE TO 10 ATMOSPHERES HOWEVER, IT FAILED TO INFLATE. THE PHYSICIAN SUBSEQUENTLY WITHDREW THE INTACT PRODUCT FROM THE PATIENTS BODY AND REPLACED IT WITH AN IDENTICAL DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, THE DEVICE ANALYSIS REVEALED A PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21540698 ↗
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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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