MAXI LD 4171660LRecalls & reported problems
Cordis US Corp. · MAXI LD 7F 16X6 110CM · Class 2
Data updated Oct 13, 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 20705032002575), received between Feb 16, 2018 and Feb 16, 2018 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2018Burst Container or Vessel; Burst Container or Vessel
DURING USE, IT WAS REPORTED THAT THE MAXI LD RUPTURED. THERE WAS NO PATIENT INJURY. THE TARGET LESION IS THE RIGHT FEMORAL VEIN WHICH WAS SLIGHTLY TORTUOUS AND CALCIFIED. THE DEVICE WAS REPLACED WITH A NON CORDIS BALLOON AND THE PROCEDURE WAS COMPLETED. THE DEVICE WAS PREP NORMALLY. THERE WAS NO DIFFICULTY INFLATING THE BALLOON DURING PREP. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THERE WAS NO DAMAGES NOTED AFTER THE DEVICE WAS REMOVED FROM THE PATIENT. THE DEVICE DID NOT KINKED ANYTIME DURING THE PROCEDURE. THE CONTRAST TO SALINE RATIO WAS "NORMAL". BOSTON SCIENTIFIC INFLATION DEVICE WAS USED, WHICH WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THROUGH THE GUIDE CATHETER. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THERE WAS NO DAMAGES NOTED TO THE DEVICE PACKAGING. THE DEVICE IS NOT AVAILABL
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7276726 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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