SaberX RadianzRecalls & reported problems across all models
Cordis US Corp. · 24 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 24 models of SaberX Radianz by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2019 and Aug 7, 2026 — classified as 5 injuries, 63 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (61 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 Vessel61
- Detachment of Device or Device Component3
- Difficult to Remove3
- Deflation Problem2
- Inflation Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- No Consequences Or Impact To Patient9
- Bone Cement Implantation Syndrome1
SaberX Radianz models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SaberX Radianz R51007004LCatheter, angioplasty, peripheral, transluminal13 reports
- SaberX Radianz R51004004LCatheter, angioplasty, peripheral, transluminal10 reports
- SaberX Radianz R51006004LCatheter, angioplasty, peripheral, transluminal7 reports
- SaberX Radianz R51006006LCatheter, angioplasty, peripheral, transluminal5 reports
- SaberX Radianz R51005004LCatheter, angioplasty, peripheral, transluminal5 reports
- SaberX Radianz R51003004LCatheter, angioplasty, peripheral, transluminal5 reports
- SaberX Radianz R51005006LCatheter, angioplasty, peripheral, transluminal2 reports
- SaberX Radianz R51005025LCatheter, angioplasty, peripheral, transluminal2 reports
- SaberX Radianz R51004030LCatheter, angioplasty, peripheral, transluminal2 reports
- SaberX Radianz R51008006LCatheter, angioplasty, peripheral, transluminal2 reports
- SaberX Radianz R51006015LCatheter, angioplasty, peripheral, transluminal2 reports
- SaberX Radianz R51004006LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51003010LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51003030LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51004015LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51005030LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51005010LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51005002LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51002015LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51002520LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51002030LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51005003LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51005020LCatheter, angioplasty, peripheral, transluminal1 report
- SaberX Radianz R51010010LCatheter, 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.
InjuryAug 7, 2026Deflation Problem
As reported, a 7mm X 4cm 190 cm SABERX RADIANZ percutaneous transluminal angioplasty (PTA) balloon catheter was unable to deflate after inflation in the body despite the application of negative pressure. Pressure could still be applied while the balloon remained inflated. Negative pressure was continuously applied, and after the pressure dropped slightly, the device was pulled back to the aorta and intentionally ruptured using the back end of the guidewire to complete the procedure. There was no reported patient injury. There was no problem during device preparation. There was no difficulty removing the protective balloon cover or any sterile packaging components, and a contralateral approach was not used. The device was used during PCPS removal. The target vessel was the femoral vein. At the target site, the vessel characteristics included no calcification, moderate tortuosity, 50% stenosis, a moderate acute angle, and moderate bifurcation. The vessel characteristics for accessing the target site included no calcification, no tortuosity, no stenosis, no acute angle, and moderate bifurcation. The device was not placed into an acute bend at any point during the procedure, successful
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50172334 ↗MalfunctionApr 13, 2026Burst Container or Vessel
AS REPORTED, A 4MM 15CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) BALLON RUPTURED AT 6AT< DURING THE FIRST INFLATION. A 4MM 10CM SABERX BALLOON WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS OCCURRED DURING A CONTRALATERAL APPROACH FOR A SUPERFICIAL FEMORAL ARTERY (SFA) CASE. THE SABERX WAS USED AFTER PASSAGE OF AN UNKNOWN .014 WIRE. 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 24861126 ↗MalfunctionApr 8, 2026Burst Container or Vessel
AS REPORTED, A 6 MM X 40 MM SABER X-RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 10 ATM DURING PRE-DILATATION IN A TRANSRADIAL INTERVENTION (TRI) ILIAC CASE. A NEW DEVICE OF THE SAME SIZE WAS OPENED AND USED, AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED FOR PRE-DILATATION IN AN ILIAC CASE VIA TRI APPROACH. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE. NO DEVICE DAMAGE WAS NOTED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING OR REMOVING THE PROTECTIVE BALLOON COVER. AN IPSILATERAL APPROACH WAS USED. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. NO ANOMALIES WERE NOTED AFTER THE DEVICE WAS DELIVERED TO THE LESION. THE DEVICE WAS ABLE TO BE REMOVED EASILY AND WAS REMOVED INTACT IN ONE PIECE. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. NO ANOMALIES WERE NOTED DURING INFLATION WITH POSITIVE PRESSURE. THERE WAS NO ANOMALY PREVENTING DEVICE INFLATION. THE INDEFLATOR GAUGE DID NOT INDICATE A LOSS OF PRESSURE. THE DEVICE WAS DISCARDED AT SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817977 ↗MalfunctionApr 6, 2026Burst Container or Vessel
AS REPORTED, THE BALLOON ON A 7MM X 4CM SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT NOMINAL PRESSURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS BEING USED FOR PRE-DILATION OF AN EXTERNAL ILIAC ARTERY (EIA) STENOTIC LESION. 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 24790332 ↗MalfunctionApr 3, 2026Burst Container or Vessel
AS REPORTED, THE BALLOON ON A 6MM X 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 4 ATMOSPHERES (ATM). A 6MM X 4CM SABERX RADIANZ PTA BALLOON CATHETER WAS OPENED AND EXPANDED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A TRANS-RADIAL INTERVENTION (TRI) TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). AN UNKNOWN GUIDEWIRE WAS INSERTED PRIOR TO USE OF THE 6MM SABERX RADIANZ PTA BALLOON CATHETER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24776356 ↗MalfunctionMar 2, 2026Burst Container or Vessel
AS REPORTED, THE 3MM 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED DURING INFLATION. THE PROCEDURE WAS COMPLETED USING A NEW 4MM 4CM SABERX RADIANZ DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DIFFICULTY WAS ENCOUNTERED WHEN REMOVING IT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET, OR ANY STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE NOTED PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU AND MAINTAINED NEGATIVE PRESSURE. THE INTENDED PROCEDURE WAS TRI (TRANSRADIAL INTERVENTION) TARGETING THE ILIAC ARTERY. THE LESION WAS SEVERELY CALCIFIED WITH MODERATE VESSEL TORTUOSITY AND 90% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). NO RESISTANCE OR FRICTION WAS EXPERIENCED WHEN INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NOT PLACED IN AN ACUTE BEND, AND NO KINKING OCCURRED DURING USE. A 50:50 CONTRAST-TO-SALINE RATIO WAS USED. THE DEVICE WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24483810 ↗MalfunctionFeb 18, 2026Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 5MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BEFORE REACHING NOMINAL PRESSURE. A 4MM X 4CM SABERX RADIANZ PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO PERFORM DILATION. AN UNKNOWN DRUG-COATED BALLOON (DCB) WAS THEN USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A SUPERFICIAL FEMORAL ARTERY (SFA) PROCEDURE IN WHICH A RADIAL APPROACH WAS USED. AN UNKNOWN GUIDEWIRE WAS INSERTED PRIOR TO USE OF THE 5MM X 4CM SABERX RADIANZ PTYA BALLOON CATHETER. ADDITIONAL INFORMATION WAS REQUESTED BUT AS UNAVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378266 ↗MalfunctionFeb 9, 2026Burst Container or Vessel
AS REPORTED, THE 4MM 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED FOR SEVERE CALCIFIED STENOSIS OF THE SUPERFICIAL FEMORAL ARTERY. DURING THE SECOND DILATION, THE BALLOON RUPTURED AT ABOUT 5 ATM, WHICH DID NOT REACH THE SPECIFIED PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE OBTAINED AFTER MULTIPLE ATTEMPTS MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292848 ↗MalfunctionJan 21, 2026Burst Container or Vessel
AS REPORTED, THE BALLOON OF A SABERX RADIANZ 6MM4CM 190 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) RUPTURED DURING INFLATION AT THE LESION SITE. ANOTHER BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS REPORTED TO HAVE BEEN STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WERE NO DIFFICULTIES REMOVING IT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET, OR STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE OBSERVED PRIOR TO INSERTION, AND THE DEVICE WAS PREPPED ACCORDING TO THE IFU AND MAINTAINED NEGATIVE PRESSURE NORMALLY. THE INTENDED PROCEDURE INVOLVED THE ILIAC ARTERY WITH A LEFT EXTERNAL ILIAC ARTERY TARGET, WHERE THE VESSEL EXHIBITED SEVERE CALCIFICATION, MODERATE TORTUOSITY, 100% STENOSIS, A MODERATE ACUTE ANGLE, AND MODERATE BIFURCATION. ACCESS VESSEL CHARACTERISTICS INCLUDED MODERATE TORTUOSITY, A MODERATE ACUTE ANGLE, AND MODERATE BIFURCATION. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION, AND THE BALLOON RUPTURED AT APPROXIMATELY 6 ATMOSPHERES. THE RUPTURE DID NOT OCCUR WITHIN A STENT. IOPAMIRON CONTRAST MEDIA WAS USED AT A HALF CONTRAST-TO-SALINE RATIO. THE SAME INDEFLATOR HAD BEEN USED SUCCESSFULLY W
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24132347 ↗MalfunctionJan 5, 2026Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 7MM X 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 10 ATMOSPHERES (ATM). A NON-CORDIS 7 X 4 BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE POST-DILATION. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT THE EXTERNAL ILIAC ARTERY (EIA) IN WHICH AN UNKNOWN SMART STENT WAS PLACED. 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 23955913 ↗MalfunctionDec 11, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 6MM 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED. THE BALLOON RUPTURED AT ITS NOMINAL PRESSURE. ANOTHER BALLOON WAS USED TO MANAGE THE SITUATION AND THE PROCEDURE ENDED WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET, OR OTHER STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGE WERE OBSERVED BEFORE INSERTION. THE DEVICE WAS PREPPED PER THE IFU AND MAINTAINED NEGATIVE PRESSURE. THE INTENDED PROCEDURE WAS AN ENDOVASCULAR THERAPY (EVT) TARGETING THE LEFT EXTERNAL ILIAC ARTERY. THE LESION HAD SEVERE CALCIFICATION, MODERATE VESSEL TORTUOSITY, AND 80% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE OR FRICTION NOTED WHEN INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR GUIDE CATHETER. NO DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NOT PLACED IN AN ACUTE BEND AND DID NOT KINK DURING USE. THE DEVICE WILL NOT BE RETUR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23782357 ↗MalfunctionNov 21, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
AS REPORTED, THE UNKNOWN SHEATH AND UNKNOWN WIRE WERE ALREADY IN THE BODY WHILE PULLING THE 2.5MM 20CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON OUT. THE BALLOON GOT CAUGHT ON SOME CALCIUM AND TORE THE BALLOON. DR SLOWLY PUSHED THE WIRE BACK IN UNTIL IT CAUGHT ONTO THE BALLOON AND WAS ABLE TO PULL OUT BALLOON. 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 23617254 ↗MalfunctionAug 28, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 6MMX 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 4 ATMOSPHERES (ATM). AN UNKNOWN DEVICE WAS SUCCESSFULLY USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A TRANS-RADIAL INTERVENTION (TRI) PRE-DILATION. 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 22911823 ↗MalfunctionAug 21, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 4MM 4CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS BEING USED DURING "PRE-STAGE". THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED BUT COULD NOT BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22860766 ↗MalfunctionAug 19, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 8MM 6CM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED DURING POST-DILATATION OF THE 6X60MM SMART ILIAC STENT. THE BALLOON RUPTURED AT NOMINAL PRESSURE. ANOTHER PRODUCT 8-40MM SABERX WAS USED TO RE-DILATE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE OBTAINED AFTER MULTIPLE ATTEMPTS MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22841580 ↗
Other Cordis US Corp. products
- MYNXGRIP2 models · 2,276 reports · 2 recalls
- Cordis ExoSeal Vascular Closure Device3 models · 1,279 reports
- MYNX CONTROL2 models · 534 reports
- POWERFLEX56 models · 306 reports
- SABER51 models · 270 reports
- Cordis S.M.A.R.T. Control Vascular Stent System30 models · 99 reports · 2 recalls
- INFINITI20 models · 107 reports
- AVIATOR19 models · 75 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page