MAXI LD 4161640SRecalls & reported problems
Cordis US Corp. · MAXI LD 7F 16X4 80CM · 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 20705032002209), received between Feb 17, 2020 and Feb 17, 2020 — 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 17, 2020Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, A 16MMX4CM 80CM MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER SUDDENLY RUPTURED WITHIN THE PERMISSIBLE NORMAL RANGE PRESSURE. THEREFORE, PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT AS AN ANGIOGRAPHY WAS PERFORMED AND DID NOT FIND ANY PARTS OF THE BALLOON FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE CONTRAST MEDIA USED WAS UNKNOWN WITH A FIFTY-FIFTY (50:50) SALINE RATIO. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE EVENT CAUSED A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDIT
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9716880 ↗
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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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