MAXI LD 4162240LRecalls & reported problems
Cordis Corporation · MAXI LD 7F 22X4 110CM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032002377), received between Jan 22, 2019 and Mar 10, 2023 — classified as 1 injury, 1 malfunction.
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
Device problems
- Burst Container or Vessel2
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2023Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE MID PART OF THE BALLOON OF A 7F MAXI LD 22MM X 4CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATION CATHETER RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16525306 ↗InjuryJan 22, 2019Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, A RUPTURE OF THE BALLOON ON THE MAXI LD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) OCCURRED AND ITS TIP DETACHED FROM THE CATHETER, BEING SECURED ONLY BY THE GUIDEWIRE OF ACCESS. TO AVOID DAMAGES, MANEUVERS WERE MADE FOR REMOVAL AFTER MUCH DIFFICULTY. THE EXPIRATION DATE OF THE DEVICE WAS EXCEEDED AT THE TIME OF USE.
Patient problems: Foreign Body In Patient
MAUDE report 8268861 ↗
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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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