Charger™ H74939206080470Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729804673), received between Oct 28, 2019 and Dec 10, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 DURING THE PROCEDURE, THE BALLOON CATHETER AND GUIDEWIRE BECAME STUCK TOGETHER AND COULD NOT BE WITHDRAWN.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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. AN 8.0 X40, 75CM CHARGER BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIFTH INFLATION AT 18 ATMOSPHERES FOR APPROXIMATELY 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504535 ↗
• MalfunctionMar 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH THORACIC AORTIC DISSECTION. THE GREATER THAN 95% SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE GREATER THAN 100 DEGREES ANGLE BETWEEN THE SUBCLAVIAN AND THE AORTA AND NON-CALCIFIED THORACIC AORTA. AN 8.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 6-7 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS WITHDRAWN FROM THE PATIENT DIRECTLY AND WAS REPLACED WITH ANOTHER OF THE SAME DEVICE, AND AN 10X40 EPIC STENT WAS IMPLANTED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18973107 ↗
• MalfunctionMar 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VEIN IN THE LEFT UPPER ARM A 8.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION, HOWEVER, DURING FIRST INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED AND BALLOON LEAK WAS NOTED. 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 13895296 ↗
• MalfunctionJan 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN 8.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION IN AN ENDOVASCULAR ANGIOPLASTY OF UPPER LIMB VEINS . HOWEVER, UPON REACHING 16 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13349362 ↗
• MalfunctionSep 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 8.0 X40, 75CM AND ANOTHER CHARGER BALLOON CATHETERS WERE ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOONS RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12522770 ↗
• MalfunctionMar 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT COMMON ILIAC ARTERY. AN 8.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED AGAINST THE LESION AT 10 ATMOSPHERES FOR APPROXIMATELY 90 SECONDS. WHEN THE PHYSICIAN WENT TO INCREASE THE PRESSURE BEYOND THE NOMINAL PRESSURE, THE BALLOON DEFLATED. BALLOON RUPTURE WAS NOTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9805527 ↗
• MalfunctionOct 28, 2019Device Contaminated During Manufacture or Shipping; Packaging Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. IT WAS OBSERVED THAT AN 8.0 X40, 75CM CHARGER BALLOON CATHETER PRODUCT BOX AND DEVICE PACKAGE WAS RECEIVED DAMAGED AND THE PRODUCT POUCH WAS COMPROMISED. THE CHARGER WAS NOT USED FOR A PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9244358 ↗