SaberX Radianz R51006030LRecalls & reported problems
Cordis Corporation · SABERX RADIANZ 6MM30CM 190 · Class 2
All models of SaberX Radianz (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032081273), received between Sep 12, 2024 and Nov 24, 2025 — classified as 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2025Burst Container or Vessel; Burst Container or Vessel
THE DEVICE WAS NOT RETURN FOR EVALUATION AS ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23632906 ↗MalfunctionSep 12, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 6MM X 30CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WITHIN ITS NOMINAL PRESSURE. A NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN ENDOVASCULAR THERAPY (EVT) PROCEDURE TO TREAT AN ILIAC AND SUPERFICIAL FEMORAL ARTERY (SFA) LESION WHICH WAS A CHRONIC TOTAL OCCLUSION (CTO). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20200837 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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