SaberX Radianz R51002030LRecalls & reported problems
Cordis US Corp. · SABERX RADIANZ 2MM30CM 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 20705032081785), received between Feb 4, 2020 and Feb 4, 2020 — 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.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2020Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, A 2MM X 30CM 155CM SABER RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED BEFORE FIVE ATMOSPHERES (5ATMS) DURING ITS INITIAL INFLATION. THEREFORE, THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT AND REPLACED WITH ANOTHER NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A LEFT CRITICAL LIMB ISCHEMIA (CLI) AND A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). A NON-CORDIS INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES. AN IPSILATERAL APPROACH WAS MADE WITH A NON-CORDIS SHEATH. THE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9664785 ↗
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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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