MAXI LD 4161460LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032002087), received between Dec 21, 2020 and Feb 23, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 18, 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.

• MalfunctionFeb 23, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 7F 14MM X 6CM X 110CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER RUPTURED WHEN FILLING. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369454 ↗
• MalfunctionDec 21, 2020Difficult to Remove; Difficult to Remove

  AS REPORTED, WHEN USING THE 7F 14MM X 6MM X 110CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER WAS UNABLE TO BE REMOVED FROM THE 8F CORDIS PUNCTURE SHEATH, SO THE BALLOON AND SHEATH WERE REMOVED AS A UNIT TOGETHER. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS AN ILIAC VEIN COMPRESSION. THERE WAS NO DAMAGE TO THE DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE BALLOON CATHETER LOOKED NORMAL WHEN TAKEN FROM ITS PACKAGING. THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO DIFFICULTY FLUSHING THE CATHETER WITH SALINE. THE DEVICE WAS KINKED. THE ACCESS SITE LOCATION WAS THE RIGHT FEMORAL VEIN. THE TARGET LESION WAS THE LEFT ILIAC VEIN. THE LESION WAS NOT CALCIFIED, TORTUOUS, AND DID NOT HAVE VESSEL ANGULATION. THE PERCENTAGE OF STENOSIS WAS 60%. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING INTO THE PATIENT. THERE WAS NO DIFFICULTY ACCESSING THE LESION WITH A GUIDEWIRE. A NON-CORDIS GUIDEWIRE WAS USED. THE OTHER DEVICES USED WITH THE PRODUCT DID NOT KINK NOR BEND AT ANY TIME. THERE WAS NO UNU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047165 ↗