Charger™ H74939206061510Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729804321), received between Jun 13, 2019 and Sep 17, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Difficult to Remove; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810489 ↗
• MalfunctionApr 14, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON TEAR OCCURRED. VASCULAR ACCESS SITE WAS OBTAINED VIA ANTERIOR TIBIAL (AT) ARTERY. THE 100% STENOSED, 130MMX5MM, TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY OR PROXIMAL POPLITEAL ARTERY. AFTER A 6F GUIDE CATHETER WAS INSERTED AND A LASER ATHERECTOMY WAS UTILIZED OVER A .014 WIRE, A 6.0 X150, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED AT NOMINAL PRESSURE FOR 1 MINUTE. HOWEVER, UPON REMOVAL, THE BALLOON WING WAS DIFFICULT TO PASS THROUGH FROM THE HEMOSTATIC ASPECT OF THE SHEATH. ADDITIONALLY, FORCE WAS CAUTIOUSLY APPLIED TO COAX THE BALLOON OUT OF THE SHEATH CAUSING THE BALLOON TO TEAR AS IT WAS REMOVED OUT OF THE PATIENT'S BODY. THE BALLOON WAS REMOVED INTACT, AND NO DETACHED FRAGMENTS NOTICED INSIDE THE PATIENT. FURTHERMORE, AFTER CONTRAST INJECTION AND VISUALIZATION OF THE TARGET LESION, ADDITIONAL ANGIOPLASTY WAS PERFORMED USING A 5X150X150 STERLING BALLOON CATHETER. THE STERLING BALLOON WAS REMOVED, AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY FURTHER COMPLICATIONS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747018 ↗
• MalfunctionFeb 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X150, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 7 ATMOSPHERES (NOMINAL IS 10 ATMOSPHERES) FOR LESS THAN 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE REMOVED INTACT FROM THE PATIENT BODY. A 7MM X 40MM X 130CM INNOVA STENT WAS THEN USED TO APPOSED THE LESION WITH ANOTHER CHARGER BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441577 ↗
• MalfunctionJan 30, 2023Stretched; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25-JAN-2023. IT WAS REPORTED THAT THE SHAFT WAS STRETCHED. A 6.0 X150, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INSERTED OVER THE GUIDEWIRE. HOWEVER, WHEN THE BALLOON WAS ADVANCED THROUGH THE SHEATH, IT STRETCHED OUT. THE BALLOON WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264695 ↗
• MalfunctionJul 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. FOLLOWING STENT IMPLANTATION, A 6.0 X150, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, THE BALLOON BURST DURING INFLATION. THE DEVICE WAS REMOVED SUCCESSFULLY AND NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 6.0X 150 CHARGER BALLOON CATHETER. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15061779 ↗
• MalfunctionFeb 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT LEG VESSEL. A 6.0 X150, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767036 ↗
• MalfunctionJun 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X150, 135CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT BELOW NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CHARGER BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696432 ↗