Charger™ H74939206100470Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729803799), received between Feb 13, 2019 and Mar 27, 2025 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A 10.0 X40, 75CM CHARGER WAS USED FOR DILATION. DURING THE PROCEDURE, A SUCCESSFUL ANGIOGRAPHY WITH A 6 FRENCH SHEATH, WAS PERFORMED AND THE LESION WAS CROSSED WITH A WIRE. IVUS WAS ALSO SUCCESSFULLY PERFORMED. HOWEVER, THERE WAS A LEAK AT THE BALLOON PACKAGE OPENING, PREVENTING BALLOON DILATION. THE BALLOON RUPTURED ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707557 ↗
• MalfunctionMar 25, 2025Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS SITUATED IN THE PERIPHERAL ARTERY. A 10.0 X 40 MM, 75 CM CHARGER BALLOON CATHETER WAS SELECTED FOR DILATION. THE PROCEDURE COMMENCED WITH A SUCCESSFUL ANGIOGRAPHY PERFORMED VIA A 6 FRENCH SHEATH, AND THE LESION WAS SUCCESSFULLY CROSSED WITH A GUIDEWIRE. ADDITIONALLY, INTRAVASCULAR ULTRASOUND (IVUS) WAS EFFECTIVELY CONDUCTED TO FURTHER ASSESS THE LESION. HOWEVER, DURING THE PREPARATION FOR BALLOON DILATION, A LEAK WAS DETECTED AT THE BALLOON PACKAGE OPENING. THIS ISSUE LED TO THE BALLOON RUPTURING UPON THE FIRST INFLATION ATTEMPT. CONSEQUENTLY, THE PLANNED DILATION COULD NOT BE COMPLETED WITH THE INITIAL DEVICE. THE PROCEDURE WAS SUBSEQUENTLY ADAPTED, AND AN ALTERNATIVE DEVICE WAS UTILIZED TO ACHIEVE THE DESIRED OUTCOME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688544 ↗
• MalfunctionSep 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED VESSEL. A 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS PREPARED AND ADVANCED FOR TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT REVISION PROCEDURE. HOWEVER, THE BALLOON RUPTURED UPON INITIAL INFLATION AT 10 ATMOSPHERES FOR 15 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY FRAGMENTS LEFT IN THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CHARGER BALLOON. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242960 ↗
• MalfunctionAug 23, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC ARTERY. A 10.0 X 40, 75CM CHARGER BALLOON CATHETER WAS ADVANCE FOR DILATATION. UPON REMOVAL, THE BALLOON WAS DEFLATED AND WAS UNABLE TO TRACK OVER WIRE. THE BALLOON WAS REMOVED INTACT TOGETHER WITH THE WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052298 ↗
• MalfunctionDec 29, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON BURST CIRCUMFERENTIALLY. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13105904 ↗
• MalfunctionDec 3, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924105 ↗
• InjuryOct 20, 2021Break; Material Rupture; Detachment of Device or Device Component; Break; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT SHAFT BREAK, BALLOON RUPTURE, AND DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH END STAGE RENAL DISEASE (ESRD) WITH LEFT UPPER EXTREMITY ARTERIOVENOUS GRAFT (AVG) AT RISK OF THROMBOSIS. THE PATIENT UNDERWENT INTERVENTIONAL RADIOLOGY (IR) FOR EVALUATION AND RECANALIZATION OF STENTS. A 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS THEN ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTICED THAT THE BALLOON RUPTURED AND THERE WAS FRAGMENTATION AS WELL AS DISTRACTION FROM CATHETER MID STENT. THE PHYSICIAN PERFORMED A SECOND CRISS CROSS ACCESS UPSTREAM FOR SNARING AND REMOVAL OF THE DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665541 ↗
• MalfunctionMar 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NOT HEAVILY CALCIFIED AND NON-TORTUOUS LEFT COMMON ILIAC ARTERY. A 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT APPROXIMATELY 8 ATMOSPHERES, THE BALLOON RUPTURED. ANOTHER 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED; HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON ALSO RUPTURED. BOTH DEVICES WERE REMOVED SAFELY FROM THE PATIENT'S BODY AND IT WAS NOTED THAT BOTH BALLOONS HAD VISIBLE PINHOLES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11409042 ↗
• MalfunctionMar 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NOT HEAVILY CALCIFIED AND NON- TORTUOUS LEFT COMMON ILIAC ARTERY. A 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT APPROXIMATELY 8 ATMOSPHERES, THE BALLOON RUPTURED. ANOTHER 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED; HOWEVER, DURING INFLATION AT 8 ATMOSPHERES, THE BALLOON ALSO RUPTURED. BOTH DEVICES WERE REMOVED SAFELY FROM THE PATIENT'S BODY AND IT WAS NOTED THAT BOTH BALLOONS HAD VISIBLE PINHOLES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408929 ↗
• MalfunctionAug 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. A 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON HAD A HOLE AND COULD NOT BE BLOWN UP WITH THE INFLATION DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10407723 ↗
• InjuryJun 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED SUBCLAVIAN ARTERY. A 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE PORTION OF THE BALLOON THAT RUPTURED WAS REMOVED SUCCESSFULLY WITH A SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS OKAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10168365 ↗
• MalfunctionJul 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY. A 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED USING AN EXPRESS STENT'S SYSTEM BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8786199 ↗
• MalfunctionFeb 20, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON  31-JAN-2019. IT WAS REPORTED THAT BALLOON LEAK OCCURED. THE TARGET LESION WAS LOCATED IN THE BRACHIAL. A 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON COULD NOT FULLY INFLATE DUE TO LEAK. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PINHOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8356471 ↗
• MalfunctionFeb 13, 2019Inflation Problem; Physical Resistance/Sticking; Inflation Problem; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-JAN-2019. IT WAS REPORTED THAT DIFFICULTY TO LOAD WIRE AND BALLOON FAILURE TO INFLATE OCCURRED. A 10.0 X40, 75CM CHARGER BALLOON CATHETER WAS SELECTED FOR USE; HOWEVER, THE TECHNICIAN NOTED THAT THE THREADS WERE BAD AND COULD NOT THREAD SOMETHING INTO THE CATHETER. WHEN THEY FINALLY FOUND A WAY TO GET AROUND, THE BALLOON WOULD NOT COME UP. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PINHOLE LEAK.

  Patient problems: No Patient Involvement

  MAUDE report 8336656 ↗