SaberX Radianz R51003030LRecalls & reported problems
Cordis US Corp. · SABERX RADIANZ 3MM30CM 190 · Class 2
All models of SaberX Radianz (24)
Data updated Oct 18, 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 20705032081464), received between Sep 12, 2023 and Sep 12, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2023Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem
AS REPORTED, AN 8 X 100 SMART CONTROL ILIAC STENT WAS OPENED BY MISTAKE. THERE WAS NO DEVICE MALFUNCTION, AND THE DEVICE WAS NOT CLINICALLY USED. THERE WAS NO REPORTED PATIENT INJURY. THE COMPLAINT DEVICE WAS USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO) OF THE SUPERFICIAL FEMORAL ARTERY (SFA) FROM THROMBOTIC ILIAC. OTHER UNKNOWN DEVICES WERE USED TO COMPLETE THE PROCEDURE. ADDITIONALLY, A 3MM X30CM 155 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WAS USED FOR THE SUPERFICIAL FEMORAL ARTERY, BUT ¿CANDY WRAPPED¿ AND A PINHOLE RUPTURED OCCURRED AS WELL DURING ITS SECOND INFLATION. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER UNKNOWN DEVICE AND BLOOD FLOW BECAME STABLE. THERE WAS NO REPORTED PATIENT INJURY. THE SMART CONTROL WILL NOT BE RETURNED FOR INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17731177 ↗
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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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