MAXI LD 4162040LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032002278), received between May 31, 2018 and May 23, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 16, 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.

• MalfunctionMay 23, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 20MM X 40MM 110CM MAXI LD F7 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 6 ATMOSPHERES (ATM), PRIOR TO BEING FULLY INFLATED. AFTER CONFIRMING THAT THERE WAS NO ADVERSE EFFECT ON THE PATIENT, THE DEVICE WAS REMOVED, AND A 20MM DIAMETER NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 70% ESOPHAGEAL STENOSIS. THE TARGET SITE WAS CALCIFIED BUT SHOWED NO SIGNS OF TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED WHILE DURING INSERTION OF THE DEVICE. THE DEVICE WAS ABLE TO ADVANCE TOWARD THE LESION AND CROSS THE LESION WITHOUT ISSUE. THE DEVICE WAS NEVER PUT INTO AN ACUTE BEND AND DID NOT KINK DURING ITS USE. AFTER THE BALLOON RUPTURE, THE MAXI LD BALLOON CATHETER WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14468724 ↗
• MalfunctionJul 23, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 20MM X 40MM X 110CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED, HOWEVER, IT RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY (I.E., MAINTAIN NEGATIVE PRESSURE). THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY MISTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216086 ↗
• MalfunctionApr 28, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF THE 7F 110 20 X 40 MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WAS INFLATED BUT IT RUPTURED AT 4 OR 5 ATMOSPHERES. IT WAS REPLACED WITH ANOTHER NON-CORDIS BALLOON CATHETER AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS DISCARDED BY MISTAKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10006092 ↗
• MalfunctionMay 31, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE FOR POST DILATION OF A STENT GRAFT, IT WAS REPORTED THAT THE MAXI LD RUPTURED WITHIN ITS RATED BURST PRESSURE. THERE WAS NO PATIENT INJURY. THE MAXI BALLOON WAS REPLACED WITH THE SAME PRODUCT AND THE PROCEDURE WAS COMPLETED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7557990 ↗