Charger™ H74939206120670Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729803874), received between May 13, 2019 and Apr 6, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19-MAR-2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE MODERATELY STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LOWER EXTREMITY VEIN. A 12.0 X60, 75CM CHARGER BALLOON CATHETER WAS SELECTED FOR USE BUT THE BOTTOM OF THE BALLOON WAS LEAKING SALINE CONTRAST WHEN FLUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11622083 ↗
• InjuryJan 12, 2021Leak/Splash; Difficult to Remove; Detachment of Device or Device Component; Leak/Splash; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A LEAK, DIFFICULTY REMOVING THE DEVICE, AND UNRETRIEVED DEVICE FRAGMENTS LEFT IN THE PATIENT. A 12MM X 60MM X 75CM CHARGER BALLOON CATHETER WAS SELECTED FOR USE IN A LEFT UPPER ARM BALLOON ANGIOPLASTY AND STENTING PROCEDURE. THE LEFT UPPER SUBCLAVIAN VEIN HAD TWO PREVIOUSLY PLACED STENTS. ONE STENT APPEARED TO HAVE BEEN PLACED THROUGH THE STRUTS OF THE OTHER. SOME FRACTURES WERE PRESENT WITH EXPOSED NITINOL STRUTS. UPON INFLATION AND DEFLATION IN THE AREA OF THE FRACTURED STENT, BLOOD WAS NOTED IN THE INFLATION DEVICE, WHICH INDICATED A PIN HOLE OR TEAR IN THE BALLOON MATERIAL. RESISTANCE WAS FELT UPON REMOVAL. SOME BALLOON MATERIAL REMAINED ON THE STENT STRUT. A SECOND WIRE WAS PLACED NEXT TO THE FIRST AND USED TO COMPLETE THE CASE. A 12MM X 60MM VENOUS WALLSTENT WAS PLACED OVER THE SECOND WIRE AND POST DILATED WITH A 10MM X 40MM BALLOON, WHICH OPENED THE IN-STENT RESTENOSIS AND TRAPPED ANY BALLOON MATERIAL BEHIND THE STENT. ANGIOGRAPHIC AND INTRAVASCULAR ULTRASOUND (IVUS) IMAGING PROVED TO BE WIDELY PATENT. BOTH THE FIRST AND SECOND WIRES WERE REMOVED WITHOUT INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11155458 ↗
• MalfunctionJul 24, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED. A 12.0 X60, 75CM CHARGER BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10319860 ↗
• MalfunctionOct 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X60, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE BALLOON WAS INFLATED AT 3 ATMOSPHERES, THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9151510 ↗
• MalfunctionJun 9, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC VEIN. A 12.0 X60, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND 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 8681348 ↗
• 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 8605248 ↗