Charger™ H74939206072010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729804505), received between Nov 26, 2018 and Sep 1, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE LEG. A 7.0 X200MM, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR HARM WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10477720 ↗
• MalfunctionJul 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. TWO 7.0 X200MM, 135CM AND A 7.0 X150MM, 135CM CHARGER BALLOON CATHETERS WERE USED SUBSEQUENTLY FOR DILATATION. HOWEVER, THE BALLOONS WOULD NOT HOLD THE PRESSURE AND RUPTURED. BLOOD WAS IN THE INDEFLATOR UPON INFLATION AND IT WAS NOTED THAT THERE WAS A RIP. THE PROCEDURE WAS COMPLETED WITH A 4.0 BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780737 ↗
• MalfunctionJul 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. TWO 7.0 X200MM, 135CM AND A 7.0 X150MM, 135CM CHARGER BALLOON CATHETERS WERE USED SUBSEQUENTLY FOR DILATATION. HOWEVER, THE BALLOONS WOULD NOT HOLD THE PRESSURE AND RUPTURED. BLOOD WAS IN THE INDEFLATOR UPON INFLATION AND IT WAS NOTED THAT THERE WAS A RIP. THE PROCEDURE WAS COMPLETED WITH A 4.0 BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780735 ↗
• MalfunctionNov 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 7X100X120 EPIC VASCULAR STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. A 7.0 X200, 135CM CHARGER AND A 7.7.0X220150-HYBRID STERLING BALLOON CATHETER WERE SELECTED FOR DILATATION. HOWEVER, BOTH BALLOONS RUPTURED BEFORE NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT AND BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102094 ↗