MAXI LD 4161440LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032002063), received between Feb 19, 2020 and Mar 6, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE DOCTOR REPORTED THAT THE MAXI LD 14X4 BALLOON BURST AFTER BEING INFLATED RESPECTING THE NOMINAL PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, BOTH WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE. TWO IMAGES WERE NOTED ON THE FILE. ON THE FIRST IMAGE THE POUCH OF A MAXI LD REF 416-1440L LOT 82246340 IS NOTED. ON THE SECOND IMAGE A PLASTIC BAG WITH THE DEVICE INSIDE IS OBSERVED, HOWEVER THE UNIT CANNOT BE INSPECTED, THUS NO ANOMALIES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486772 ↗
• MalfunctionDec 27, 2021Burst Container or Vessel; Burst Container or Vessel

  DURING PREP OF THE MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON BURST AT FIVE ATMOSPHERE BECAUSE THE PRESSURE RESISTANCE WAS INSUFFICIENT. THERE WAS NO PATIENT INJURY. THE DEVICE WAS REPLACED WITH A NEW UNKNOWN PRODUCT TO COMPLETE THE PROCEDURE. THE DEVICE WILL BE AVAILABLE FOR ANALYSIS. THE VESSEL IS THE ILIAC VEIN WHICH WAS STENOSED CALCIFIED AND MODERATELY TORTUOUS. THE DEVICE WAS PREPPED PER THE INSTRUCTION FOR USE (IFU) WITH NO KINKS NOTED. THERE WAS NO DIFFICULTY REMOVING THE HOOP, PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090702 ↗
• MalfunctionFeb 19, 2020Leak/Splash; Leak/Splash

  AS REPORTED THAT HALFWAY THROUGH THE OPERATION, BUBBLES WERE FOUND WHEN A 7F 14MMX4CM 110CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS RE-PUMPED. THEREFORE, THE SURGEON IMMEDIATELY REMOVED THE BALLOON CATHETER FROM THE PATIENT AND RE-IMPLANTED WITH THE SAME SIZE MAXI LD BALLOON CATHETER AND THE OPERATION WAS CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. AN ILIAC VENOUS BALLOON DILATATION WAS PERFORMED TO A PATIENT WITH ILIAC VENOUS COMPRESSION SYNDROME. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9727231 ↗