Charger™ H74939206041510Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729804048), received between Aug 4, 2020 and Aug 10, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2021Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). PHYSICIAN CROSSED RETROGRADE FROM THE POSTERIOR TIBIAL ARTERY AND GAINED ACCESS FROM THE CONTRALATERAL GROIN. THE PHYSICIAN WAS ABLE TO FLOSS THE GUIDEWIRE THROUGH THE 6F SHEATH OUT THE GROIN ACCESS. A 4.0 X150, 135CM CHARGER BALLOON CATHETER WAS ADVANCED; HOWEVER, IT WAS NOTICED THAT ADVANCING WAS EXTREMELY DIFFICULT. THE PHYSICIAN PERFORMED MULTIPLE INFLATIONS UP AND DOWN THE LENGTH OF SFA. A LOT OF RESISTANCE WAS FELT WHEN THE PHYSICIAN TRIED TO REMOVE THE BALLOON. THE BALLOON STOPPED MOVING BACK AND THE CATHETER STRETCHED AND SNAPPED APPROXIMATELY 5 CM FROM THE PROXIMAL HUB. THE PHYSICIAN USED A 6F NON-BSC GUIDE CATHETER AND ADVANCED IT OVER THE BALLOON CATHETER TO TRY TO CAPTURE THE BALLOON IN THE GUIDE CATHETER. HE WAS ABLE TO ADVANCE THE GUIDE CATHETER TO THE PROXIMAL BALLOON RO MARKER, BUT UNABLE TO ADVANCE THE GUIDE CATHETER OVER THE BALLOON. HE MANIPULATED THE GUIDE CATHETER AND THE CHARGER BALLOON CATHETER TOGETHER PULLING IN SHORT STOKES TO REMOVE THE PORTION OF THE REMAINING CHARGER BALLOON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304691 ↗
• MalfunctionAug 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS BURR WAS SELECTED FOR USE BUT FAILED TO REACH OPTIMUM SPEED DURING INITIAL TESTING OUTSIDE THE PATIENT'S BODY. ANOTHER PERIPHERAL ROTALINK PLUS BURR WAS USED AND WORKED JUST FINE. A 4.0 X150, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10363181 ↗