Charger™ H74939206120470Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729803867), received between Jan 17, 2019 and Oct 18, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE LESS THAN 75% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED AORTIC AND COMMON ILIAC ARTERY. A 12.0 X40, 75CM CHARGER BALLOON CATHETER WAD ADVANCED INTO THE DISTAL AORTA FOR DILATATION. HOWEVER, THE BALLOON RUPTURED DURING THE INITIAL INFLATION FOR A FEW SECONDS PRIOR TO REACHING THE NOMINAL PRESSURE. THE DEVICE WAS REMOVED INTACT, AND A 12.0 X40, 75CM 035 NON-BOSTON SCIENTIFIC BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20484496 ↗
• MalfunctionJun 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A 12.0 X40, 75CM CHARGER BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, IT WAS NOTICED THAT THE BALLOON WAS LEAKING GAS WHEN THE PRESSURE REACHED 8 ATMOSPHERES AND A PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11991732 ↗
• MalfunctionMar 23, 2021Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 12.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT ABOVE NOMINAL PRESSURE, THE BALLOON RUPTURED AND OPENED LIKE AN UMBRELLA WHICH MADE THE BALLOON DIFFICULT TO BE TAKEN OUT FROM THE PATIENT'S BODY AND THROUGH THE SHEATH. THE DEVICE WAS ABLE TO BE REMOVED INTACT FROM THE PATIENT'S BODY AND NO BALLOON FRAGMENT WERE LEFT BEHIND. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554330 ↗
• MalfunctionApr 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED OR DILATION. HOWEVER, DURING INITIAL INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9919006 ↗
• MalfunctionFeb 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. TWO 12.0 X40, 75CM CHARGER BALLOON CATHETERS WERE USED FOR DILATATION CONSECUTIVELY. HOWEVER, DURING THE INITIAL INFLATION AT 5-6 ATMOSPHERES FOR 3 SECONDS, THE BALLOONS RUPTURED. BOTH DEVICES WERE COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A 10MM CHARGER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9699338 ↗
• MalfunctionFeb 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. TWO 12.0 X40, 75CM CHARGER BALLOON CATHETERS WERE USED FOR DILATATION CONSECUTIVELY. HOWEVER, DURING THE INITIAL INFLATION AT 5-6 ATMOSPHERES FOR 3 SECONDS, THE BALLOONS RUPTURED. BOTH DEVICES WERE COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A 10MM CHARGER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9699336 ↗
• MalfunctionNov 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X40, 75CM CHARGER BALLOON CATHETER WAS SELECTED FOR A SUBCLAVIAN ANGIOPLASTY PROCEDURE. DURING PREPARATION, SALINE WAS PUT INTO THE BALLOON AND UPON CHECKING THE BALLOON, A PIN HOLE WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 9336205 ↗
• MalfunctionMay 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC. AFTER STENT PLACEMENT POST DILATION WAS PERFORMED WITH A CHARGER BALLOON CATHETER (12X40, 12X60 AND 10X60). EACH CHARGER BALLOON CATHETER RUPTURED. A FOURTH CHARGER (12X60) WAS USED SUCCESSFULLY DILATED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8605253 ↗
• MalfunctionJan 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED ILIAC VEIN. A 12.0 X 40, 75CM CHARGER CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING ANGIOPLASTY AT 4 ATMOSOPHERES FOR 5 SECONDS THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT BODY.THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257217 ↗