MAXI LD 4171460LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032002445), received between Jan 3, 2017 and Apr 28, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THREE MAXI LD BALLOONS ON ONE CASE WERE USED AND ALL THREE BURST AT NOMINAL PRESSURE. THERE WERE TWO 14X6 BALLOONS AND ONE 14X4 BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCTS WERE STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE BALLOONS FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVERS, STYLETS, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE BALLOONS WERE PREPPED PER THE IFU. THE DEVICE PREPPED NORMALLY WITHOUT DIFFICULTY. THE INTENDED LESION WAS IN THE COMMON FEMORAL (VENOUS). THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOONS THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY NOTED WHILE ADVANCING THE BALLOONS THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE SAME INFLATION DEVICE WAS USED WITH OTHER DEVICES DURING THE PROCEDURE. ALL DEVICES WERE REMOVED INTACT FROM THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE NOT SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16835237 ↗
• MalfunctionJan 3, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A MAXI LD 7F 14X6 110CM BALLOON RUPTURE DURING POST-DILATATION. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN USED A MAXI LD FOR A VEIN CASE AND SUCCESSFUL PRE-DILATATION USING THE MAXI-LD BALLOON. THE PHYSICIAN THEN PLACED 3 WALL STENTS IN THE VEIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6217954 ↗