Charger™ H74939206120870Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729803881), received between Sep 19, 2018 and Sep 26, 2025 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (21 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionApr 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A 12.0 X 80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR POST-DILATION AFTER PLACING THE TWO 14 X 60CM WALLSTENT SELF-EXPANDING STENTS. HOWEVER, THE BALLOON RUPTURED WHILE APPLYING PRESSURE UPON FIRST INFLATION AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19145130 ↗
• MalfunctionMar 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ILIAC VEIN COMPRESSION STENOSIS. THE MORE THAN 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A 35 GUIDEWIRE WAS PASSED, AND ANGIOGRAPHY SHOWED STENOSIS AFTER EXPANSION OF BALLOON WITH DIAMETER OF 8, 10 AND 12. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION FOR STENT IMPLANTATION. HOWEVER, DURING SECOND INFLATION AT 6-7 ATMOSPHERES FOR SEVERAL SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED IN A NORMAL WAY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18957957 ↗
• MalfunctionJan 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT A FILTER IMPLANTATION WITH THE TARGET LESION LOCATED IN THE INFERIOR VENA CAVA. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18603252 ↗
• MalfunctionAug 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR POST DILATION AFTER A VENOUS STENT IMPLANTATION. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561251 ↗
• MalfunctionApr 2, 2023Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, THE BALLOON WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON MATERIAL ITSELF BROKE, AND NOT THE SHAFT. THE TARGET LESION WAS 70% STENOSED, NON-TORTUOUS, AND NON-CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16661064 ↗
• MalfunctionJul 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989043 ↗
• MalfunctionMay 4, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283777 ↗
• InjuryMar 17, 2022Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Break; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE, SHAFT BREAK, BALLOON DETACHMENT AND REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-CALCIFIED RIGHT SUBCLAVIAN VEIN. AFTER A 12X80 NON-BOSTON SCIENTIFIC STENT WAS DEPLOYED, A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, THE BALLOON RUPTURED AFTER BEING INFLATED MULTIPLE TIMES. DURING REMOVAL OF THE BALLOON, IT BECAME STUCK IN THE ARTERIOVENOUS (AV) GRAFT PORTION DUE TO SCARRING AND THE SHAFT BROKE. THE BALLOON WAS ALSO FRAGMENTED OFF OF THE SHAFT AND REMAINED IN THE PATIENT. AN ATTEMPT WAS MADE TO SNARE THE DETACHED FRAGMENT, BUT IT WAS UNSUCCESSFUL. SUBSEQUENTLY, THE PHYSICIAN HAD TO PERFORM A CUT DOWN AND REMOVED ALL PIECES OF THE DEVICE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13794721 ↗
• MalfunctionNov 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE LESION WAS SEVERELY STENOSED AND THE BALLOON RUPTURED AFTER BEING INFLATED ONCE FOR FEW SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12901492 ↗
• MalfunctionJul 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE MILDLY STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ILIAC VEIN. A 10.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED AND USED TO DILATE THE LESION; HOWEVER, DURING THE INITIAL INFLATION AT LESS WORKING PRESSURE FOR FEW SECONDS, THE BALLOON RUPTURED. ANOTHER 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED AND USED TO DILATE THE LESION; HOWEVER, DURING THE INITIAL INFLATION AT LESS WORKING PRESSURE FOR FEW SECONDS, THE BALLOON ALSO RUPTURED. BOTH DEVICES WERE SIMPLY PULLED OUT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105160 ↗
• MalfunctionApr 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X80MM, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638182 ↗
• MalfunctionApr 7, 2021Material 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. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626813 ↗
• MalfunctionFeb 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X80MM, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334728 ↗
• MalfunctionJan 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X80MM, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 5 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11221909 ↗
• MalfunctionSep 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING SECOND INFLATION, IT WAS NOTED THAT THE BALLOON COULD NOT INFLATE AND IT BURSTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS INFLATED UNDER WORKING PRESSURE BEFORE IT RUPTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10478624 ↗
• MalfunctionMay 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10103569 ↗
• MalfunctionApr 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER LIMB VESSEL. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION FOR FEW SECONDS THE BALLOON RUPTURED, A VISIBLE PINHOLE WAS NOTED AFTER A PRESSURE TEST WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9946988 ↗
• MalfunctionApr 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT ILIOFEMORAL VEIN THROUGH THE LEFT ANTERIOR TIBIAL VEIN. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X80, 75CM CHARGER BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THERE WAS BLOOD FLOWED BACK INTO THE PRESSURE PUMP. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914934 ↗
• MalfunctionNov 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH DEEP VEIN THROMBOSIS. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED TO THE LESION LOCATED IN THE LEFT POPLITEAL VEIN. THE BALLOON WAS INFLATED, BUT IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE. AFTER PRESSURE WAS RELEASED IT WAS OBSERVED THAT THERE WAS BLOOD IN THE CONNECTION TUBE OF THE PUMP. THE BALLOON WAS REMOVED AND WAS INFLATED OUTSIDE OF THE PATIENT. IT WAS OBSERVED THAT THE BALLOON WAS LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9377085 ↗
• MalfunctionMay 2, 2019Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT BALLOON LEAK OCCURED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS FOUND OUT THAT THE CONTRAST AGENT WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8574293 ↗
• MalfunctionJan 29, 2019Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JAN2019. IT WAS REPORTED THAT FAILURE TO INFLATE OCCURED. THE 90% STENOSED TARGET LESION LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILLIAC VEIN (LEFT LOWER LIMB). A 12.0 X80, 75CM CHARGER WAS USED TO DELIVER. HOWEVER, BALLOON COULD NOT DILATE AFTER 5 SECONDS AT 10 ATMOSPHERE. THE PHYSICIAN COMPLETED THE PROCEDURE BY RETRIEVING THE DEVICE AND BY USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON LONGITUDINAL TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285104 ↗
• MalfunctionSep 19, 2018Material 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 AT AN OVERLAP BETWEEN TWO PREVIOUSLY IMPLANTED 14X90MM WALLSTENTS. HOWEVER, THE BALLOON COULD NOT BE FULLY DILATED AND RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME. NO COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7890211 ↗