SaberX Radianz R51005010LRecalls & reported problems
Cordis US Corp. · SABERX RADIANZ 5MM10CM 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 20705032081617), received between Apr 8, 2024 and Apr 8, 2024 — 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 8, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, DURING THE INFLATION OF A 5MM X 10CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO 6 ATMOSPHERES (ATM) THE PRESSURE OF THE BALLOON STARTED TO DROP, AND THE DEVICE WAS REMOVED. AFTER REMOVAL, THE BALLOON WAS INFLATED OUTSIDE OF THE PATIENT AND A PIN HOLE RUPTURE WAS CONFIRMED. A NEW 5MM X 30CM SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED INJURIES TO THE PATIENT DURING THE USE OF THE SABERX PTA BALLOON CATHETER. THE DEVICE WAS BEING USED TO TREAT A PERFORATION OF THE POPLITEAL ARTERY DURING A PROCEDURE IN WHICH THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD A CHRONIC TOTAL OCCLUSION (CTO). THE PERFORATION WAS CONFIRMED TO HAVE OCCURRED PRIOR TO THE USE OF THE SABERX RADIANZ PTA BALLOON CATHETER. THE DEVICE WAS DELIVERED VIA AN IPSILATERAL ANTEGRADE APPROACH AND HAD TRAVELED THROUGH THE HEAVILY CALCIFIED CTO. AN UNKNOWN GUIDEWIRE WAS USED AND HAD CROSSED THE LESION. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED WITH A 2:1 CONTRAST TO SALINE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19058880 ↗
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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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