MAXI LD 4171440SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032002438), received between May 11, 2017 and May 9, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 7F MAXI LD 14X4 BALLOON RUPTURED DURING A CASE. IT NEVER ACHIEVED PRESSURE. THIS BALLOON SIMPLY RUPTURED BEFORE ANY SIGNIFICANT PRESSURE WAS ATTAINED. NOTHING OUT OF THE ORDINARY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896743 ↗
• MalfunctionMar 1, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER AN UNKNOWN STENT WAS IMPLANTED, TWO 7F MAXI LD 14X4 80CM BALLOONS RUPTURED. THE FIRST MAXI BALLOON WAS USED, BUT IT RUPTURED AT 4 ATM. A SECOND MAXI (SAME SIZE) WAS USED, AND IT RUPTURED IN THE SAME AREA AT 4 ATM. THERE WAS NO REPORTED PATIENT INJURY. THIS OCCURRED DURING A LEFT VENOGRAM. THE DEVICE WERE DISPOSED/DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461635 ↗
• MalfunctionMar 1, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER AN UNKNOWN STENT WAS IMPLANTED, TWO 7F MAXI LD 14X4 80CM BALLOONS RUPTURED. THE FIRST MAXI BALLOON WAS USED, BUT IT RUPTURED AT 4 ATM. A SECOND MAXI (SAME SIZE) WAS USED, AND IT RUPTURED IN THE SAME AREA AT 4 ATM. THERE WAS NO REPORTED PATIENT INJURY. THIS OCCURRED DURING A LEFT VENOGRAM. THE DEVICE WERE DISPOSED/DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461633 ↗
• InjuryMay 25, 2021Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A 7F 14 X 4 X 80CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WHEN POST DILATING AN UNKNOWN STENT. WHEN THE PHYSICIAN TRIED TO PULL THE BALLOON THROUGH THE UNKNOWN SHEATH, THE BALLOON DETACHED FROM THE CATHETER. THE SEPARATED SEGMENT OF THE BALLOON WAS REMOVED VIA DOING A SURGICAL CUT DOWN ON THE GROIN AND PICKING OUT THE SEPARATED PIECE. THE BALLOON WAS NOT REMOVED INTACT THE BALLOON SHEARED OFF THE DEPLOYMENT CATHETER WHILE TRYING TO REMOVE FROM VASCULAR SHEATH. THE INTENDED PROCEDURE WAS A VENOGRAM WITH PTA AND STENTING OF ILIAC VEIN. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, BALLOON COVER OR WHEN REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS ANY DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE CONTRAST TO SALINE RATIO WAS 50/50 . THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER VE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11878191 ↗
• MalfunctionMay 11, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE 14X40MM MAXI LD BALLOON CATHETER RUPTURED AT FOUR ATMOSPHERES (4 ATM) ON CALCIUM. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NON CORDIS BALLOON CATHETER. THERE WAS NO PATIENT INJURY. THE TARGET LESION IS THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH WAS MODERATELY CALCIFIED WITH 60% STENOSIS. THERE WAS NO VESSEL TORTUOSITY. THE DEVICE PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO DEFECTS DURING PREP. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE CONTRAST TO SALINE RATIO WAS 50/50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, THE GUIDE CATHETER, OR THE VESSEL. THERE DIFFICULTY CROSSING THE LESION. THE CATHETER HAS NEVER IN AN ACUTE BEND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6560065 ↗