SABERRecalls & reported problems across all models
Cordis US Corp. · 51 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 270
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 0
We found 51 models of SABER by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 270 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2016 and Mar 16, 2026 — classified as 16 injuries, 254 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (155 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 SABER problems
Device problems
- Burst Container or Vessel155
- Leak/Splash46
- Detachment of Device or Device Component34
- Partial Blockage13
- Deflation Problem12
- Difficult to Remove9
- Material Rupture7
- Crack5
Patient problems
- No Clinical Signs, Symptoms or Conditions171
- No Consequences Or Impact To Patient83
- No Known Impact Or Consequence To Patient9
- Foreign Body In Patient3
- Calcium Deposits/Calcification1
- Complete Neonatal Hearing Loss1
- Failure of Implant1
- Insufficient Information1
SABER models
51 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SABER 48005004SCatheter, angioplasty, peripheral, transluminal19 reports
- SABER 48004004SCatheter, angioplasty, peripheral, transluminal17 reports
- SABER 48003004SCatheter, angioplasty, peripheral, transluminal16 reports
- SABER 48003030XCatheter, angioplasty, peripheral, transluminal15 reports
- SABER 48002515XCatheter, angioplasty, peripheral, transluminal14 reports
- SABER 48003015XCatheter, angioplasty, peripheral, transluminal14 reports
- SABER 48004015XCatheter, angioplasty, peripheral, transluminal13 reports
- SABER 48002020XCatheter, angioplasty, peripheral, transluminal11 reports
- SABER 48006030XCatheter, angioplasty, peripheral, transluminal10 reports
- SABER 48006004SCatheter, angioplasty, peripheral, transluminal9 reports
- SABER 48003004XCatheter, angioplasty, peripheral, transluminal9 reports
- SABER 48006004XCatheter, angioplasty, peripheral, transluminal8 reports
- SABER 48006010XCatheter, angioplasty, peripheral, transluminal8 reports
- SABER 48003025XCatheter, angioplasty, peripheral, transluminal7 reports
- SABER 48004010XCatheter, angioplasty, peripheral, transluminal7 reports
- SABER 48004004XCatheter, angioplasty, peripheral, transluminal6 reports
- SABER 48005010SCatheter, angioplasty, peripheral, transluminal5 reports
- SABER 48002010XCatheter, angioplasty, peripheral, transluminal5 reports
- SABER 48006010SCatheter, Angioplasty, Peripheral, Transluminal4 reports
- SABER 48010002SCatheter, angioplasty, peripheral, transluminal4 reports
- SABER 48004025XCatheter, angioplasty, peripheral, transluminal4 reports
- SABER 48002030XCatheter, angioplasty, peripheral, transluminal4 reports
- SABER 48003006XCatheter, angioplasty, peripheral, transluminal4 reports
- SABER 48005030XCatheter, angioplasty, peripheral, transluminal4 reports
- SABER 48005010XCatheter, angioplasty, peripheral, transluminal3 reports
- SABER 48002525XCatheter, angioplasty, peripheral, transluminal3 reports
- SABER 48002025XCatheter, angioplasty, peripheral, transluminal3 reports
- SABER 48002506XCatheter, angioplasty, peripheral, transluminal3 reports
- SABER 48003520XCatheter, angioplasty, peripheral, transluminal3 reports
- SABER 48004030XCatheter, angioplasty, peripheral, transluminal3 reports
- SABER 48006006XCatheter, angioplasty, peripheral, transluminal3 reports
- SABER 48007010XCatheter, angioplasty, peripheral, transluminal3 reports
- SABER 48008004XCatheter, angioplasty, peripheral, transluminal3 reports
- SABER 48003010SCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48003002SCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48010004SCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48006008XCatheter, Angioplasty, Peripheral, Transluminal2 reports
- SABER 48008010XCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48004002SCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48002004XCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48002006XCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48003008SCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48002502SCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48002504SCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48006020SCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48007002SCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48003010XCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48005002XCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48007002XCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48007003XCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48004020SCatheter, angioplasty, peripheral, transluminal1 report
Recent SABER adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2026Material Frayed; Material Split, Cut or Torn
AS REPORTED, WHEN ADVANCING A 6MM X 30MM SABER .018 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER OVER AN UNKNOWN GUIDEWIRE, THE PHYSICIAN NOTICED A TEAR HALFWAY DOWN ON THE CATHETER SHAFT. THE DEVICE WAS REMOVED FROM THE GUIDEWIRE BEFORE BEING INSERTED INTO THE PATIENT, AND A NEW UNKNOWN BALLOON WAS OPENED TO FINISH THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT IN-STENT RESTENOSIS WITH THE LEG. THE DEVICE WAS PROPERLY STORED AND OPENED IN THE STERILE FIELD AND WAS PREPPED PRIOR TO BEING ADVANCED OVER THE UNKNOWN GUIDEWIRE. THE USER WAS TRAINED TO THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607944 ↗MalfunctionFeb 13, 2026Burst Container or Vessel
AS REPORTED, AFTER CROSSING WITH A .018 WIRE, PRE-DILATION WAS PERFORMED WITH A 3MM 30CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. DURING BALLOON INFLATION, IT RUPTURED WHEN PRESSURE REACHED 9 ATM; THE RATED BURST PRESSURE FOR THIS MODEL IS 14 ATM. IT WAS REPLACED WITH THE SAME MODEL SABER BALLOON TO COMPLETE THE PROCEDURE, AND NO PATIENT INJURY OCCURRED. THE PATIENT PRESENTED WITH LEFT LOWER LIMB ARTERIOSCLEROSIS OBLITERANS WITH AN ESTIMATED ~30 CM LONG-SEGMENT SUPERFICIAL FEMORAL ARTERY OCCLUSION. 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 24337994 ↗MalfunctionJan 30, 2026Leak/Splash
AS REPORTED, THE BALLOON OF A 3MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FOUND TO HAVE AN AIR LEAK DURING NEGATIVE PREPARATION. THE DEVICE WAS NOT USED INSIDE THE PATIENT, AND A NON-CORDIS BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE EVENTS OR INJURIES TO THE PATIENT. THE INTENDED PROCEDURE WAS PERIPHERAL ARTERY ANGIOPLASTY OF THE LOWER LIMB. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER, AND THE COVER DID NOT TWIST OR ROTATE DURING REMOVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223277 ↗MalfunctionJan 21, 2026Detachment of Device or Device Component
AS REPORTED, THE PROXIMAL EDGE OF THE BALLOON ON AN 8MM X 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS SEPARATED OUT OF THE BOX. A SEPARATION WAS ALSO NOTED TO THE DISTAL PORTION OF THE PLASTIC BALLOON COVERING AND THERE WAS DIFFICULTY REMOVING THE BALLOON COVER. THE DEVICE DID NOT ENTER THE PATIENT AND WAS NOT USED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PEDAL ACCESS PROCEDURE IN WHICH A 4F 10CM RAIN TIBIAL PEDAL CATHETER SHEATH INTRODUCER (CSI) WAS USED. THERE WAS NO DAMAGE TO THE OUTER PACKAGING FOR THE SABER PTA BALLOON CATHETER OBSERVED PRIOR TO OPENING THE DEVICE. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING IT FROM THE PACKAGING. THE BALLOON COVER WAS NOT ROTATED OR TWISTED DURING REMOVAL. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24136023 ↗MalfunctionDec 24, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
AS REPORTED, THE 6MM 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED DURING DILATION, AND THE PROXIMAL SEGMENT FRACTURED/SPLIT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU. THERE WERE NO DIFFICULTIES REMOVING IT FROM THE HOOP, BALLOON COVER, OR STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGE WERE OBSERVED BEFORE INSERTION, AND THE DEVICE WAS PREPARED NORMALLY, MAINTAINING NEGATIVE PRESSURE. THE INTENDED PROCEDURE INVOLVED RUPTURE OF THE FENESTRATION MEMBRANE IN A THORACIC AORTIC STENT. THE VESSEL SHOWED NO CALCIFICATION, TORTUOSITY, OR STENOSIS, AND THE DEVICE WAS NOT USED FOR CHRONIC TOTAL OCCLUSION. NO RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER, NOR WHEN ADVANCING THE BALLOON OR CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND, AND THE BALLOON DID NOT KINK DURING USE. A 1:1 CONTRAST-TO-SALINE RATIO WAS USED. THE PROCEDURE WAS COMPLETED USING A BACKUP NON-CORDIS BALLOON. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888515 ↗MalfunctionDec 24, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 3MM 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED BEFORE NOMINAL EXPANSION, AND PRODUCT PERFORMANCE COULD NOT BE ACHIEVED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS BEING USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888477 ↗MalfunctionDec 12, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 4×40MM 90CM SABER OTW .018 PTA DILATATION CATHETER RUPTURED WHILE DILATING A CALCIFIED LESION DURING A SUPERFICIAL FEMORAL ARTERY TREATMENT PERFORMED UNDER BODY-SURFACE ULTRASOUND. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE INVOLVED TREATMENT OF A CALCIFIED LESION UNDER ULTRASOUND GUIDANCE. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791053 ↗MalfunctionNov 26, 2025Crack; Crack
AS REPORTED, A LONG CRACK WAS FOUND ON ONE SIDE OF THE 4MM 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. THE PROCEDURE WAS COMPLETED USING ATHERECTOMY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS PROPERLY STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS O DAMAGE NOTED TO THE PACKAGING AND NO DIFFICULTIES ENCOUNTERED DURING UNPACKING. THERE WERE NO ISSUES REMOVING THE PRODUCT FROM THE HOOP, THE BALLOON COVER, OR ANY STERILE COMPONENTS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656063 ↗InjuryNov 25, 2025Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component
AS REPORTED, A 3MM X 15CM SABER .018 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DID NOT MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS THEN USED IN PATIENT. THE BALLOON WAS INFLATED UP TO RBP, AND THERE WAS A LOSS OF PRESSURE DURING INFLATION DUE TO RUPTURE. ADDITIONALLY, DEFLATION TOOK LONGER THAN USUAL. AFTER BALLOON INFLATION AND DEFLATION OF A 3MM X 15CM SABER .018 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE DEVICE WAS REMOVED. HOWEVER, ANGIOGRAPHY REVEALED THAT THE MARKER BAND OF THE SABER .018 PTA BALLOON CATHETER WAS STILL VISIBLE. UPON INSPECTION, IT WAS FOUND THAT THE SHAFT HAD FRACTURED, LEAVING A PORTION INSIDE OF THE PATIENT¿S VESSEL. APPROXIMATELY HALF OF THE SHAFT WAS RETRIEVED USING AN UNKNOWN SNARE, WHILE THE REMAINING PORTION COULD NOT BE REMOVED AND REQUIRED SURGICAL EXTRACTION BY OPENING THE VESSEL. RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE PRIOR TO OBSERVING THE SEPARATION, SPECIFICALLY FROM THE VESSEL AND THROUGH THE SHEATH/INTRODUCER GUIDE. THREE IMAGES WERE PROVIDED WHICH SHOW THE SEPARATION OCCURRED AT THE BALLOON PORTION OF THE DEVICE. THE PATIENT DID NOT SUFFER ANY SERIOUS INJURIES AND WAS SENT T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645920 ↗MalfunctionOct 22, 2025Leak/Splash; Leak/Splash
AS REPORTED, THE 2.5MM 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON BODY WAS DAMAGED. THIS RESULTED IN AIR LEAKAGE DURING INFLATION. THE ISSUE OCCURRED DURING BALLOON INFLATION IN THE ANTERIOR TIBIAL ARTERY. THE PROCEDURE WAS COMPLETED BY REPLACING WITH A NEW SABER 2.5*150 DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE VESSEL EXHIBITED MILD TORTUOSITY WITHOUT CALCIFICATION, AND THE STENOSIS WAS APPROXIMATELY 50%. THERE WAS NO DAMAGE TO THE PACKAGING, AND NO ADDITIONAL ANOMALIES WERE NOTED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23362347 ↗MalfunctionSep 18, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 4MM X 4CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON BURST BELOW RATED BURST PRESSURE (RBP) DURING INFLATION. THE PROCEDURE WAS COMPLETED USING A NON-CORDIS DEVICE THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A SUPERFICIAL FEMORAL ARTERY (SFA) SHUNT PTA PROCEDURE. THE LESION WAS NOT CALCIFIED, VESSEL TORTUOSITY WAS SEVERE, AND THE PERCENTAGE OF STENOSIS WAS 90%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE PRODUCT WAS STORED AND PREPPED 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 ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTION INTO THE PATIENT. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER, AND NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND, AND THE BALLOON CATHETER DID NOT KINK DURING USE. THE CONTRAST TO SALINE RATIO WAS 1:1. THE DEVICE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084600 ↗MalfunctionSep 12, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, DURING INFLATION OF A 4MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO 12 ATMOSPHERES (ATM), NO BALLOON EXPANSION WAS OBSERVED. SUBSEQUENT ASPIRATION OF THE BALLOON REVEALED BLOOD WITHIN THE PRESSURE PUMP, CONSISTENT WITH A BALLOON RUPTURE. A NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A LEFT LOWER LIMB POPLITEAL ARTERY LESION. THE TARGET VESSEL HAD MODERATE CALCIFICATION, MILD TORTUOSITY, AND 80% STENOSIS. AN UNKNOWN .018 GUIDEWIRE WAS ADVANCED THROUGH THE LESION INTO THE DISTAL TRUE LUMEN, AND THE SABER PTA BALLOON CATHETER WAS POSITIONED ACROSS THE LESION PRIOR TO ATTEMPTED INFLATION. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE STERILE PACKAGING, AND THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23038833 ↗MalfunctionSep 12, 2025Leak/Splash; Leak/Splash
AS REPORTED, A 2.5MM 25CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DID NOT FULLY INFLATE. IT WAS REMOVED AND REPLACED WITH ANOTHER BALLOON OF THE SAME SIZE. AFTER SURGERY, THE OPERATOR TESTED INFLATION OUTSIDE THE BODY AND OBSERVED LEAKAGE AT ONE LOCATION. THE SURGERY PROCEEDED SMOOTHLY WITHOUT OTHER ADVERSE EFFECTS. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS OCCURRED AFTER STANDARD PROCEDURE AND WETTING, AND AFTER INSERTION INTO THE VESSEL. THE DEVICE WAS USED DURING A LOWER LIMB (BELOW THE KNEE) ARTERY OCCLUSION RECANALIZATION AND BALLOON ANGIOPLASTY. BELOW THE KNEE DILATATION. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING IT FROM THE HOOP, PROTECTIVE BALLOON COVER, OR STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGE WERE NOTED PRIOR TO INSERTION. THE DEVICE WAS PREPPED PER THE IFU AND MAINTAINED NEGATIVE PRESSURE NORMALLY. THE LESION WAS MODERATELY CALCIFIED WITH MILD VESSEL TORTUOSITY AND 70%¿80% STENOSIS. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO). NO RESISTANCE OR FRICTION OCCURRED WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER, THOUGH MILD RESISTANCE WAS ENCOUNTE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23036974 ↗MalfunctionAug 29, 2025Leak/Splash; Leak/Splash
AS REPORTED, DURING THE DILATION OF A 3MM X 25CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, BALLOON LEAKAGE OCCURRED WITH CONTRAST MEDIA "EXTRAVASATION". THE TERM ¿EXTRAVASATION¿ WAS USED TO DESCRIBE CONTRAST LEAKAGE INTO THE VESSEL LUMEN DISTALLY DURING BALLOON INFLATION. NO EXTRAVASATION INTO SURROUNDING TISSUE WAS OBSERVED AND THERE WERE NO REPORTED INJURIES TO THE PATIENT. AN UNKNOWN 3MM X 25MM BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THIS WAS DURING A PROCEDURE TO TREAT A LOWER LIMB LEFT PERONEAL ARTERY BELOW THE KNEE. THE TARGET VESSEL WAS MODERATELY CALCIFIED, NOT TORTUOUS, AND EXHIBITED 70% STENOSIS. THE DEVICE WAS STORED AND PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), WITH NO DIFFICULTY ENCOUNTERED IN REMOVING STERILE PACKAGING. NEGATIVE PRESSURE WAS MAINTAINED DURING PREPARATION. A 50:50 RATIO OF CONTRAST TO SALINE WAS USED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921245 ↗MalfunctionAug 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, WHILE ADVANCING A 3MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER OVER AN UNKNOWN GUIDEWIRE, THE TIP OF THE DEVICE SEPARATED FROM THE BALLOON. THE SEPARATION OCCURRED PRIOR TO BEING IN CONTACT WITH THE UNKNOWN SHEATH. THE DEVICE DID NOT ENTER THE PATIENT, AND THE SAME GUIDEWIRE WAS USED WITH AN UNKNOWN REPLACEMENT DEVICE. THERE WERE NO REPORTED PATIENT INJURIES. THIS WAS DURING THE FIRST USE OF THE SABER PTA BALLOON CATHETER. THE DEVICE WAS PREPPED AND INSPECTED PRIOR TO INSERTING OVER THE UNKNOWN GUIDEWIRE AND THERE WERE NO ABNORMALITIES NOTED. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER OR APPLYING NEGATIVE PRESSURE TO THE SABER PTA BALLOON. THERE WAS NO DAMAGE TO THE UNKNOWN GUIDEWIRE. THERE WAS NO RESISTANCE OR FRICTION BETWEEN THE SABER PTA AND THE GUIDEWIRE PRIOR TO THE SEPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912091 ↗
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
- Cordis S.M.A.R.T. Control Vascular Stent System30 models · 99 reports · 2 recalls
- INFINITI20 models · 107 reports
- AVIATOR19 models · 75 reports
- AVANTI11 models · 70 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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