Charger™ H74939206100870Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729803812), received between Jul 15, 2019 and Sep 21, 2026 — classified as 2 injuries, 8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Difficult to Remove; Failure to Deflate

  It was reported that the balloon could not be withdrawn requiring additional intervention.A 10.0 x80, 75cm Charger balloon catheter was advanced for dilatation. During the venous balloon dilatation procedure, the first inflation was completed successfully. However, during the second inflation attempt, the balloon could not be withdrawn. Attempts to advance the device further were also unsuccessful. The balloon was pulled back along the vessel to the sheath entry site. The device was then removed through the sheath, and a needle was used to puncture the balloon to facilitate complete extraction. The procedure was completed with another of same device. There were no patient complications as a result of this event. The patient was stable post procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841702 ↗
• MalfunctionOct 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A 10.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE PRESSURE OF THE BALLOON REACHES 8 ATMOSPHERES UPON INITIAL INFLATION, HOWEVER, THE BALLOON COULD NOT BE USED DUE TO AIR LEAK AND RUPTURED. A 10X80 PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371716 ↗
• MalfunctionSep 1, 2022Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN ILIAC VEIN. A 10.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS LEAKING CONTRAST. 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 THE BALLOON WAS TORN LONGITUDINALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15341096 ↗
• MalfunctionJul 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 10.0 X80, 75CM CHARGER BALLOON WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED DURING INFLATION AT 10 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14943797 ↗
• MalfunctionOct 4, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24SEP2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN A ILIAC VEIN. A 10.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION A LIQUID LEAKAGE WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE RETURNED ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12573432 ↗
• MalfunctionJul 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE MILDLY STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ILIAC VEIN. A 10.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED AND USED TO DILATE THE LESION; HOWEVER, DURING THE INITIAL INFLATION AT LESS WORKING PRESSURE FOR FEW SECONDS, THE BALLOON RUPTURED. ANOTHER 12.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED AND USED TO DILATE THE LESION; HOWEVER, DURING THE INITIAL INFLATION AT LESS WORKING PRESSURE FOR FEW SECONDS, THE BALLOON ALSO RUPTURED. BOTH DEVICES WERE SIMPLY PULLED OUT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105154 ↗
• MalfunctionDec 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND TORTUOUS ILIAC ARTERY. A 10.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS INFLATED AT 14 ATMOSPHERES, CONTRAST AGENT LEAKAGE WAS NOTED. THE DEVICE WAS WITHDRAWN AND CHECKED, AND IT WAS FOUND THAT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11015369 ↗
• MalfunctionDec 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LEFT COMMON ILIAC VEIN. A 10.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 11 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10959036 ↗
• MalfunctionMar 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT HAD ILIAC VENOUS COMPRESSION SYNDROME. VASCULAR ACCESS WAS GAINED VIA THE LEFT ILIAC FEMORAL VEIN THROUGH THE LEFT ANTERIOR TIBIAL VEINS. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 8.0 X80, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING INFLATION AT 8 ATMOSPHERES (ATM). THE BALLOON RUPTURED AND BLOOD FLOWED BACK TO THE PUMP. SO, A 10.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING INFLATION AT 9 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 10.0 X80, 75CM CHARGER BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9868234 ↗
• InjuryJul 15, 2019Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION FAILURE OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 10.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED AND SUCCESSFULLY INFLATED. HOWEVER, IT WAS NOTED THAT AFTER MULTIPLE ATTEMPTS AND WAITING FOR TWO MINUTES, THE BALLOON COULD NOT BE WITHDRAWN. SUBSEQUENTLY, THE BALLOON WAS PUNCTURED THROUGH THE BODY SURFACE WITH A NEEDLE AND THE CONTRAST AGENT WAS EXTRACTED. THE DELIVERY SHAFT WAS THEN CUT OFF AND WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8790017 ↗