SaberX Radianz R51004006LRecalls & reported problems
Cordis US Corp. · SABERX RADIANZ 4MM6CM 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 20705032081327), received between Sep 4, 2024 and Sep 4, 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
- Bone Cement Implantation Syndrome1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 4MM 6CM SABER RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED. IT WAS DELIVERED TO THE LESION AND INFLATED. HOWEVER, IT RUPTURED AT 8 ATM DURING ITS INITIAL INFLATION. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE PRODUCT WAS STORED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES ENCOUNTERED WITH REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE OBSERVED PRIOR TO INSERTION INTO THE PATIENT. THE DEVICE WAS PREPARED AS PER THE INSTRUCTIONS FOR USE AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE LESION WAS MILDLY CALCIFIED, AND THE VESSEL TORTUOSITY WAS ALSO MILD. THE STENOSIS WAS COMPLETE AT 100%, AND THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION NOTED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER, NOR WAS THERE ANY DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER DID NOT HAVE ANY ACUTE BEND
Patient problems: Bone Cement Implantation Syndrome
MAUDE report 20137179 ↗
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