MAXI LD 4171440LRecalls & reported problems
Cordis US Corp. · MAXI LD 7F 14X4 110CM · Class 2
All models of MAXI LD (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032002421), received between Apr 28, 2023 and Apr 28, 2023 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2023Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THREE MAXI LD BALLOONS ON ONE CASE WERE USED AND ALL THREE BURST AT NOMINAL PRESSURE. THERE WERE TWO 14X6 BALLOONS AND ONE 14X4 BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCTS WERE STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE BALLOONS FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVERS, STYLETS, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE BALLOONS WERE PREPPED PER THE IFU. THE DEVICE PREPPED NORMALLY WITHOUT DIFFICULTY. THE INTENDED LESION WAS IN THE COMMON FEMORAL (VENOUS). THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOONS THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY NOTED WHILE ADVANCING THE BALLOONS THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE SAME INFLATION DEVICE WAS USED WITH OTHER DEVICES DURING THE PROCEDURE. ALL DEVICES WERE REMOVED INTACT FROM THE PATIENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE NOT SAVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16835019 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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