Charger™ H74939206062010Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729804369), received between Apr 10, 2019 and Aug 9, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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.

• InjuryAug 9, 2024Difficult to Insert; Difficult to Advance; Difficult to Insert; Difficult to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE LESS THAN 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6.0 X200, 135CM CHARGER BALLOON WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE AND WAS INFLATED TWICE WITHOUT ANY ISSUE. HOWEVER, UPON REMOVAL, A SMALL DISSECTION IN THE DISTAL PORTION OF THE SFA WAS NOTICED. THE BALLOON WAS REINSERTED WITH DIFFICULTY INTO A 6FR X 45CM NON-BSC SHEATH AND WAS ADVANCED INTO THE LESION AND WAS REINFLATED OVER THE DISSECTED AREA. THE BALLOON WAS REMOVED AFTER DEFLATING; HOWEVER, THE DISSECTION REMAINED. A 7MM X 40MM INNOVA STENT WAS PLACED INTO THE LESION, AND THE SAME BALLOON WAS REINSERTED FOR POST-DILATION. NEGATIVE PRESSURE WAS APPLIED ON THE BALLOON, BUT IT WOULD NOT TRACK ON GUIDEWIRE. THE DEVICE WAS REMOVED INTACT, AND A 6MM X 40MM X 135CM CHARGER BALLOON WAS USED TO POST-DILATE THE STENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: Vascular Dissection

  MAUDE report 19951676 ↗
• MalfunctionSep 8, 2023Deflation Problem; Difficult to Remove; Stretched; Material Deformation; Deflation Problem; Difficult to Remove; Stretched; Material Deformation

  IT WAS REPORTED THAT DEFLATION ISSUE AND REMOVAL DIFFICULTIES OCCURRED. THE 50% STENOSED TARGET LESION, GREATER THAN 200MMX6MM WAS LOCATED IN THE DIFFUSED MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. AFTER LASER ATHERECTOMY WAS PERFORMED, A 6.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DOCTOR NOTICED A SLOWER THAN NORMAL BALLOON DEFLATION TIME DURING INITIAL INFLATION AT 8 ATMOSPHERES FOR 30 SECONDS. THE BALLOON WAS REMOVED USING A SURGICAL STANDARD PIN AND PULL TECHNIQUE. UPON INSPECTION, IT WAS NOTICED THAT THE BALLOON SHAFT WAS ELONGATED, STRETCHED AND KINKED IN THE MID PORTION. A 6X200 STERLING BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715926 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED THROMBOTIC OCCLUSION OF THE POPLITEAL AND ANTERIOR TIBIAL ARTERIES. THIS 6.0 X200, 135CM CHARGER BALLOON WAS SELECTED FOR USE IN A CHRONIC TOTAL OCCLUSION (CTO) SUPERFICIAL FEMORAL ARTERY (SFA) ATHERECTOMY PROCEDURE. THE CTO WAS CROSSED USING A ZIPWIRE AND RUBICON CATHETER. THE ZIPWIRE WAS REMOVED, THEN A THRUWAY GUIDEWIRE WAS PASS THROUGH THE RUBICON. THE RUBICON WAS REMOVED, THEN THE JETSTREAM CATHETER WAS UTILIZED. ONE PASS OF THE JETSTREAM WAS USED WITH BLADES DOWN IN A SLOW MANNER BY THE PHYSICIAN. IT WAS REMOVED AND EXCHANGED FOR A 6X200 CHARGER BALLOON. A COUPLE OF INFLATIONS WERE PERFORMED, FOLLOWED BY AN ARTERIOGRAM, WHICH REVEALED SLOW FLOW AND OCCLUSION AT THE POPLITEAL ARTERY. AN EXPORT CATHETER WAS USED TO REMOVE THE THROMBUS/DEBRIS. THE DEVICE WOULD NOT PASS; THEREFORE, A STERLING BALLOON WAS USED TO DILATE THE DISTAL POPLITEAL. THE BALLOON WAS REMOVED, AND THE EXPORT CATHETER WAS REINSERTED. MULTIPLE PASSES WERE PERFORMED, REMOVING SMALL PIECES OF THROMBUS/DEBRIS. SOME FLOW WAS RESTORED TO THE POPLITEAL AND PERONEAL ARTERY, WITH A CLOT AT THE ANTERIOR TIBIAL (AT) ARTERY. A ZIPWIRE WAS USED ALONG WITH A BERNSTEIN CATHETER TO

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 16589853 ↗
• MalfunctionFeb 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 6.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THIRD INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262741 ↗
• MalfunctionOct 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X200, 135CM CHARGER BALLOON, 5.0X150X150 STERLING, AND A 5.0X200X150 STERLING BALLOON CATHETERS WERE USED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOONS RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10696750 ↗
• MalfunctionApr 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON POPPED INSIDE THE PATIENT. IT WAS NOTED THAT THE BALLOON WAS ABLE TO BE DEFLATED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9979248 ↗
• MalfunctionApr 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. A 6.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION TO NOMINAL PRESSURE, A HOLE WAS NOTICED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS VESSEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967423 ↗
• MalfunctionMar 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT SUPERFICIAL ARTERY. A 6.0 X200, 135 CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST AT NOMINAL PRESSURE. THE BALLOON WAS ABLE TO REMOVED AND COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9878209 ↗
• MalfunctionFeb 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, UPON INITIAL INFLATION AT 10 ATMOSPHERES FOR 40 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9663217 ↗
• MalfunctionApr 10, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THERE WAS A HOLE ON THE BALLOON. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X200, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON FAILED TO INFLATE. WHEN THE PULLED THE BALLOON OUT, THEY FOUND OUT THAT THERE WAS A HOLE ON THE DISTAL PART OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8499880 ↗