SaberX Radianz R51005020LRecalls & reported problems
Cordis US Corp. · SABERX RADIANZ 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 20705032082003), received between Sep 19, 2022 and Sep 19, 2022 — 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 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.
MalfunctionSep 19, 2022Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 5F 5MM X 20CM 190CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AROUND ITS NOMINAL PRESSURE DURING AN INFLATION WITHIN A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) LESION. AS A RESULT, A 5MM X 25CM 155CM SABERX PTA BALLOON CATHETER WAS USED IN PLACE OF THE SABERX RADIANZ BALLOON CATHETER TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE SFA LESION HAD A 100% STENOSED CHRONIC TOTAL OCCLUSION (CTO), AND THERE WAS NO VESSEL TORTUOSITY PRESENT. A 6F BRITE-TIP RADIANZ CATHETER SHEATH INTRODUCER (CSI) WAS USED WITHOUT ISSUE TO ACCESS THE LEFT RADIAL ARTERY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). A 50/50 CONTRAST AND SALINE MIXTURE WAS USED TO PREP THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THE DEVICE WAS ABLE TO TRACK TOWARDS AND CROSS THE LESION WITHOUT DIFFICULTY. THE DEVICE WAS NEVER PUT INTO AN ACUTE BEND, AND IT DID NOT KINK DURING ITS U
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15445543 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page