Charger™ H74939206070470Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729804536), received between Jan 12, 2022 and Nov 17, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 7.0 X40, 75CM CHARGER BALLOON CATHETER WAS SELECTED TO TREAT THE LESION LOCATED IN THE LEFT UPPER EXTREMITY. DURING PROCEDURE, THE BALLOON WAS FRACTURED. THE DEVICE WAS REMOVED AND REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556963 ↗
• MalfunctionFeb 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. THE STENOSED TARGET LESION WAS LOCATED IN THE PERIPHERAL VASCULAR SYSTEM. A 7.0 X40, 75CM CHARGER BALLOON WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST BEFORE THE BURSTING PRESSURE WAS REACHED. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON DILATATION CATHETER. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PERIPHERAL VASCULAR SYSTEM. ADDITIONALLY, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 16 ATMOSPHERES FOR 5 SECONDS. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY WITHOUT ANY PROBLEM USING THE NORMAL METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18680315 ↗
• InjuryDec 21, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 7.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING PROCEDURE THE SHAFT OF THE BALLOON BROKE AND HAD TO BE SNARED OUT OF THE BODY. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030192 ↗
• MalfunctionNov 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT ENDOVASCULAR ANGIOPLASTY OF UPPER LIMB VEINS. A 7.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 7X40 BOSTON SCIENTIFIC PTA BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. THE PATIENT WAS STABLE AFTER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803766 ↗
• MalfunctionOct 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ARTIFICIAL BLOOD VESSEL OCCLUSION IN THE LEFT UPPER EXTREMITY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 7.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, ON THE SECOND INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION HAS NORMAL STENOSIS AND WAS MODERATELY CALCIFIED. THE BALLOON WAS INFLATED TWICE AT 16 AND 18 ATMOSPHERES (ATM) RESPECTIVELY FOR A FEW SECONDS, HOWEVER, ON THE SECOND INFLATION AT 18 ATM, THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668091 ↗
• MalfunctionJan 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE SEVERE STENOSED TARGET LESION WAS LOCATED IN THE HAND. A 7.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 18 ATMOSPHERES FOR FEW SECONDS, THE BALLOON RUPTURED, AND CONTRAST AGENT WAS FLOWING OUT. THE PROCEDURE WAS COMPLETED SMOOTHLY WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13234607 ↗