SaberX Radianz R51005003LRecalls & reported problems
Cordis US Corp. · SABERX RADIANZ 5MM3CM 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032081839), received between Oct 17, 2023 and Oct 17, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
InjuryOct 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THE DR. INTENDED TO USE A 5MM X 3CM X 190CM SABERX RADIANZ TO TREAT AN IN-STENT RESTENOSIS OF A STENT IN THE LEFT PROXIMAL EXTERNAL ILIAC ARTERY. HE USED A STANDARD 5FR UNKNOWN SHEATH TO GAIN ACCESS IN THE BRACHIAL ARTERY. IT WAS SUGGESTED TO USE A CORDIS BRITE TIP RADIANZ TO SUPPORT THE SABERX RADIANZ BALLOON, BUT HE DID NOT FEEL IT WOULD BE NECESSARY. THE DR WAS ABLE TO GET THE BALLOON DOWN CLOSE TO THE LESION SIGHT ALTHOUGH IT DID NOT APPEAR VERY SMOOTHLY. AT ONE POINT THE NON-CORDIS .018 GUIDEWIRE IS THOUGHT TO HAVE PROLAPSED UP INTO THE PATIENT'S AORTA. IT WAS OBSERVED THEY WERE HAVING SOME UNUSUAL ARRHYTHMIAS. THE ARRYTHMIA DID CORRECT ITSELF. ONCE THE BALLOON WAS CLOSE TO THE LESION SIGHT THE DR. THEN BEGAN TO HAVE DIFFICULTY PULLING IT BACK INTO THE CORRECT POSITION DIRECTLY OVER THE LESION. DUE TO THIS DIFFICULTY, THE DR. DECIDED TO REMOVE THE BALLOON TO SEE IF THERE WAS SOMETHING WRONG WITH IT. AS HE WAS PULLING THE BALLOON BACK TO THE SHEATH, HE BEGAN HAVING PROGRESSIVELY MORE DIFFICULTY PULLING IT BACK. HE CONTINUED PULLING THE BALLOON BACK AND THEN IT WAS OBSERVED TO HAVE BROKEN OFF AT THE BALLOON CATHETER SHAFT, WITH PART OF THE BALLOON SHAFT STILL STUCK
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17951485 ↗
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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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