SaberX Radianz R51004015LRecalls & reported problems
Cordis US Corp. · SABERX RADIANZ 4MM15CM 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 20705032081525), received between Apr 13, 2026 and Apr 13, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
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.
MalfunctionApr 13, 2026Burst Container or Vessel
AS REPORTED, A 4MM 15CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) BALLON RUPTURED AT 6AT< DURING THE FIRST INFLATION. A 4MM 10CM SABERX BALLOON WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS OCCURRED DURING A CONTRALATERAL APPROACH FOR A SUPERFICIAL FEMORAL ARTERY (SFA) CASE. THE SABERX WAS USED AFTER PASSAGE OF AN UNKNOWN .014 WIRE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24861126 ↗
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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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