SaberX Radianz R51008010LRecalls & reported problems
Cordis Corporation · SABERX RADIANZ 8MM10CM 190 · Class 2
All models of SaberX Radianz (9)
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 20705032081891), received between Feb 6, 2023 and Feb 6, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation 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.
InjuryFeb 6, 2023Deflation Problem; Deflation Problem
AS REPORTED IN THE RADIANCY STUDY, THE BALLOON OF A 5F 8MM X 10CM 190CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULD NOT DEFLATE DUE TO A KINK IN THE CATHETER JUST BEFORE THE BALLOON. IT WAS MENTIONED THAT THE SMALL KINK IN THE CATHETER WAS NOTICED PRIOR TO INSERTION OF THE DEVICE. THE PATIENT ALSO INDICATED PAIN DURING SHEATH INSERTION AS WELL AS WITHDRAWAL. PER THE DEVICE DEFICIENCIES FORM, THE STIFF END OF AN UNKNOWN .014 GUIDEWIRE WAS INSERTED INTO THE BALLOON CHANNEL TO STRAIGHTEN THE KINK IN THE BALLOON. THIS ALLOWED THE BALLOON TO BE DEFLATED AND SAFELY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT AN 80% STENOSED LESION IN THE LEFT ILIAC ARTERY WHICH HAD MODERATE CALCIFICATION. THE LEFT DISTAL RADIAL ARTERY WAS ACCESSED FOR THIS PROCEDURE WITH A 6F 11CM NON-CORDIS CATHETER SHEATH INTRODUCER (CSI). ONE ML OF HEPARIN WAS GIVEN, AND AN ANGIOGRAM WAS PERFORMED. AN UNKNOWN GUIDEWIRE WAS INSERTED ACROSS THE TARGET LESION AT THE LEFT ILIAC ARTERY AND THE 6F NON-CORDIS SHEATH WAS EXCHANGED WITH A 6F 110CM BRITE TIP RADIANZ TRANS-RADIAL GUIDING CSI. THE BRITE TIP RADIANZ CSI WAS ABLE T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16303354 ↗
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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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