SaberX RadianzRecalls & reported problems across all models
Cordis Corporation · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls
- 0
We found 9 models of SaberX Radianz by Cordis Corporation in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2019 and Apr 11, 2026 — classified as 1 death, 4 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (24 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SaberX Radianz problems
Device problems
- Burst Container or Vessel24
- Deflation Problem6
- Difficult to Remove5
- Detachment of Device or Device Component3
- Leak/Splash2
- Crack1
- Material Frayed1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Consequences Or Impact To Patient1
SaberX Radianz models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SaberX Radianz R51008004LCatheter, angioplasty, peripheral, transluminal16 reports
- SaberX Radianz R51005015LCatheter, angioplasty, peripheral, transluminal4 reports
- SaberX Radianz R51006010LCatheter, angioplasty, peripheral, transluminal3 reports
- SaberX Radianz R51007006LCatheter, angioplasty, peripheral, transluminal3 reports
- SaberX Radianz R51009004LCatheter, angioplasty, peripheral, transluminal1 death3 reports
- SaberX Radianz R51006030LCatheter, angioplasty, peripheral, transluminal2 reports
- SaberX Radianz R51010004LCatheter, angioplasty, peripheral, transluminal2 reports
- SaberX Radianz R51004010LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51008010LCatheter, angioplasty, peripheral, transluminal1 report
Recent SaberX Radianz adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2026Burst Container or Vessel
AS REPORTED, THE BALLOON ON A 7MM X 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24846453 ↗MalfunctionJan 9, 2026Material Rupture
AS REPORTED, AFTER PASSAGE OF AN UNKNOWN GUIDEWIRE, THE BALLOON ON A 5MM X 15CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) 190CM BALLOON CATHETER RUPTURED DURING THE FIRST DILATION AT ABOUT 8 ATMOSPHERES (ATM). THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS USED TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) LESION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24027114 ↗MalfunctionNov 24, 2025Burst Container or Vessel; Burst Container or Vessel
THE DEVICE WAS NOT RETURN FOR EVALUATION AS ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23632906 ↗MalfunctionNov 4, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 9MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 6 ATMOSPHERES (ATM) DURING DILATION OF THE LESION. AN 8MM X 40MM SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN ILIAC ARTERY PROCEDURE. THE TARGET VESSEL WAS SEVERELY CALCIFIED, MODERATELY TORTUOUS, AND HAD A STENOSIS OF 90%. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND DURING THE PROCEDURE, WAS ABLE TO CROSS THE LESION, DID NOT KINK, AND WAS REMOVED EASILY AND INTACT FROM THE PATIENT. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23464595 ↗MalfunctionOct 17, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove
AS REPORTED, THE BALLOON ON AN 8MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AROUND 8 ATMOSPHERES (ATM) DURING AN INFLATION AT A CALCIFIED ILIAC ARTERY LESION. THE DEVICE WAS NOT EASILY REMOVED FROM THE PATIENT; HOWEVER, IT WAS REMOVED INTACT IN ONE PIECE. A NON-CORDIS 8 X 40 DEVICE WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A TRANS RADIAL ANGIOPLASTY PROCEDURE. THE TARGET VESSEL WAS THE ILIAC ARTERY. THE TARGET SITE VESSEL WAS SEVERELY CALCIFIED AND TORTUOUS, WITH 90% STENOSIS. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND DURING THE PROCEDURE AND WAS ABLE TO CROSS THE LESION WITHOUT KINKING. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322085 ↗DeathJul 25, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, AFTER PLACING A SMART RADIANZ (UNKNOWN SIZE), POST-DILATION WAS PERFORMED USING A 9X40 SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. THERE WAS NO ISSUE OR MALFUNCTION WITH THE SMART STENT THAT WAS IMPLANTED. WITH A RATED BURST PRESSURE (RBP) OF 10 ATM, THE TRAINEE DOCTOR MISTAKENLY APPLIED 20 ATM. THE BALLOON RUPTURED AND THE VESSEL ALSO RUPTURED. THE BLOOD PRESSURE DROPPED. A NON-CORDIS COVERED STENT WAS PLACED FOR HEMOSTASIS. HOWEVER, THE PATIENT DIED THE NEXT DAY. THE PATIENT WAS UNDERGOING A TRANS-RADIAL INTERVENTION (TRI) OF THE ILIAC ARTERY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). 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. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE PREPPED NORMALLY, MAINTAINING NEGATIVE PRESSURE. THE LESION WAS MINIMALLY CALCIFIED. THE VESSEL TORTUOSITY WAS MODERATE. THE PERCENTAGE OF STENOSIS WAS 90%. THE CATHETER WAS NEVER IN AN ACUT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610717 ↗MalfunctionJul 24, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 9MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING ITS FIRST INFLATION TO 6 ATMOSPHERES (ATM) AFTER BEING DELIVERED TO THE LESION. AN UNKNOWN DEVICE WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE TARGET VESSEL WAS THE ILIAC ARTERY, WHICH EXHIBITED MILD CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS, AND THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588816 ↗MalfunctionJun 4, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, ONE CORDIS 8MM 4CM SABER RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ONE 7MM 4CM SABER RADIANZ PTA BALLOON POPPED DURING AN ANGIOGRAM PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143780 ↗MalfunctionMay 9, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 8MM 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED AT 6ATM DURING POST-DILATION OF THE SMART STENT. IT WAS REPLACED WITH A NEW BALLOON CATHETER (NON-CORDIS) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WITH CALCIFICATION ALL AROUND THE IL. A 6FR NON-CORDIS SHEATH WAS USED DURING THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21994579 ↗MalfunctionApr 28, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 7MM X 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT ABOUT 4 ATMOSPHERES (ATM) DUE TO CONTACT WITH A CALCIFIED AREA. A 7MM X 40MM SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A TRANS-RADIAL INTERVENTION (TRI) PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUDED (CTO) LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET SITE VESSEL CHARACTERISTICS INCLUDED SEVERE CALCIFICATION AND NO TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO WAS ABOUT 50%. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21918390 ↗MalfunctionJan 21, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 4MM 10CM SABERX RADIANZ WAS USED AT THE SEVERE CALCIFICATION PART OF THE ILIAC ARTERY. HOWEVER, IT RUPTURED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21204510 ↗MalfunctionNov 8, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 8MM 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED AT 8ATM WHILE BEING USED DURING AN EVT CASE. IT WAS REPLACED WITH A NEW SABER PTA (RADIANZ) (8*6), AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES IN REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU), MAINTAINING NEGATIVE PRESSURE DURING THE PREPARATION. THE INTENDED PROCEDURE TARGETED THE ILIAC REGION, WITH THE LESION CHARACTERIZED AS HAVING NO CALCIFICATION, NO VESSEL TORTUOSITY, AND 90% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO) THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. ADDITIONALLY, THERE WERE NO DIFFICULTIES ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL, CROSSING THE LESION WITH THE BALLOON CATHETER. THE CATHETER WAS NEVER IN AN ACUTE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20639511 ↗MalfunctionOct 31, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 5MM X 15CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WITHIN ITS NOMINAL PRESSURE. A NEW 5MM X 15CM SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN INTERVENTIONAL PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) LESION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577487 ↗MalfunctionOct 7, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 8 MM 4 CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED AT 8 AM. THE SAME SIZE PRODUCT WAS USED, AND THE PROCEDURE WAS PERFORMED AT 10 AM, THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS LEFT RADIAL AND BILATERAL ILIAC. THE UNKNOWN GUIDEWIRE CROSSED THE LESION AND BALLOON WAS DILATED. AN UNKNOWN STENT WAS PLACED WITHOUT ISSUE. THE STENT DID NOT EXPAND WELL, SO POST-DILATATION WAS PERFORMED WITH THE SABERX. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20385665 ↗MalfunctionSep 12, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 6MM X 30CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WITHIN ITS NOMINAL PRESSURE. A NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN ENDOVASCULAR THERAPY (EVT) PROCEDURE TO TREAT AN ILIAC AND SUPERFICIAL FEMORAL ARTERY (SFA) LESION WHICH WAS A CHRONIC TOTAL OCCLUSION (CTO). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20200837 ↗
Other Cordis Corporation products
All Cordis Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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