MAXI LD 4171840SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032002605), received between Jul 31, 2017 and Aug 16, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN 18MM X 40MM 80CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AND INFLATION TO 3 ATMOSPHERES (ATM). AS A RESULT, THE 8MM X 40MM 80CM MAXI LD PTA BALLOON CATHETER WAS REPLACED WITH 16MM X 4MM MAXI LD BALLOON CATHETER WHICH WAS USED WITHOUT ISSUE TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A LESION IN THE ILIAC VEIN. THERE WAS NO CALCIFICATION OR TORTUOSITY AT THE TARGET LESION, AND THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND USED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. A 50/50 CONTRAST AND SALINE MIXTURE WAS USED TO PREP THE BALLOON. THERE WAS NO DIFFICULTY REMOVING THE BALLOON HOOP OR PROTECTIVE COVER DURING PREPARATION. THERE WAS NO DIFFICULTY EXPERIENCED DURING INSERTION OF THE DEVICE, OR WHILE CROSSING THE LESION. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND DURING THIS PROCEDURE, AND THE DEVICE DID NOT KINK DURING ITS USE. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING REMOVAL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15232632 ↗
• MalfunctionJul 31, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE MAXI LD BALLOONS CATHETERS BURST AT TWO ATMOSPHERES (2 ATMS). THERE WERE NO PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6755630 ↗
• MalfunctionJul 31, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE MAXI LD BALLOONS CATHETERS BURST AT TWO ATMOSPHERES (2 ATMS). THERE WERE NO PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6755576 ↗