SaberX Radianz R51002520LRecalls & reported problems
Cordis US Corp. · SABERX RADIANZ 2.5MM20CM 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 20705032081730), received between Nov 21, 2025 and Nov 21, 2025 — classified as 1 malfunction.
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
- Difficult to Remove1
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.
MalfunctionNov 21, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
AS REPORTED, THE UNKNOWN SHEATH AND UNKNOWN WIRE WERE ALREADY IN THE BODY WHILE PULLING THE 2.5MM 20CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON OUT. THE BALLOON GOT CAUGHT ON SOME CALCIUM AND TORE THE BALLOON. DR SLOWLY PUSHED THE WIRE BACK IN UNTIL IT CAUGHT ONTO THE BALLOON AND WAS ABLE TO PULL OUT BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617254 ↗
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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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