MAXI LD 4161840LRecalls & reported problems
Cordis US Corp. · MAXI LD 7F 18X4 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032002230), received between Dec 18, 2019 and Dec 18, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
Patient problems
- Intimal Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2019Difficult to Remove; Difficult to Remove
DURING A VALVULOPLASTY PROCEDURE, A 18MM X 4 CM X 110 CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS QUICKLY INFLATED AND DEFLATED, HOWEVER IT DID NOT REWRAP PROPERLY AND WAS UNABLE TO BE REMOVED THROUGH THE SHEATH. THE PHYSICIAN PULLED THE SHEATH AND THE BALLOON OUT TOGETHER BUT FAILED. THEREFORE, URGENT DISSECTION SURGERY WAS REQUIRED TO REMOVE THE DEVICE AND REPAIR THE FEMORAL ARTERY. THE PRODUCT WAS REMOVED INTACT IN ONE PIECE FROM THE PATIENT. THERE WAS NO OTHER PATIENT INJURY OCCUR AFTER THE FEMORAL ARTERY DISSECTION SURGERY REPAIR. THE PATIENT IS CURRENTLY IN THE REHABILITATION. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS SINCE IT WAS DISCARDED FOLLOWING THE PROCEDURE. THE LESION WAS CALCIFIED, AND THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP AND PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED BEFORE INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREP NORMALLY AND MAINTAINED NEGATIVE PRESSURE. THE CONTRAST TO SALINE RATIO WAS 5
Patient problems: Intimal Dissection
MAUDE report 9488712 ↗
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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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