SABERRecalls & reported problems across all models
Cordis Corporation · 40 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 185
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 0
We found 40 models of SABER by Cordis Corporation in the FDA's device registry (GUDID). Together they are named in 185 adverse event reports in the FDA's MAUDE database, received between Oct 14, 2016 and Aug 11, 2026 — classified as 14 injuries, 171 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (93 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 Vessel93
- Leak/Splash28
- Detachment of Device or Device Component24
- Deflation Problem12
- Partial Blockage10
- Difficult to Remove9
- Material Frayed5
- Material Puncture/Hole5
Patient problems
- No Clinical Signs, Symptoms or Conditions105
- No Consequences Or Impact To Patient69
- No Known Impact Or Consequence To Patient6
- Foreign Body In Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Perforation of Vessels1
- Thrombosis/Thrombus1
- Vascular Dissection1
SABER models
40 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SABER 48002015XCatheter, angioplasty, peripheral, transluminal13 reports
- SABER 48008002SCatheter, angioplasty, peripheral, transluminal12 reports
- SABER 48002520XCatheter, angioplasty, peripheral, transluminal12 reports
- SABER 48005015XCatheter, angioplasty, peripheral, transluminal12 reports
- SABER 48006015XCatheter, angioplasty, peripheral, transluminal10 reports
- SABER 48002530XCatheter, angioplasty, peripheral, transluminal9 reports
- SABER 48005020XCatheter, angioplasty, peripheral, transluminal9 reports
- SABER 48004010SCatheter, angioplasty, peripheral, transluminal9 reports
- SABER 48007004SCatheter, angioplasty, peripheral, transluminal8 reports
- SABER 48008004SCatheter, angioplasty, peripheral, transluminal8 reports
- SABER 48005025XCatheter, angioplasty, peripheral, transluminal8 reports
- SABER 48002510XCatheter, angioplasty, peripheral, transluminal6 reports
- SABER 48004020XCatheter, angioplasty, peripheral, transluminal6 reports
- SABER 48006020XCatheter, angioplasty, peripheral, transluminal6 reports
- SABER 48002002SCatheter, angioplasty, peripheral, transluminal6 reports
- SABER 48005006XCatheter, angioplasty, peripheral, transluminal5 reports
- SABER 48003008XCatheter, angioplasty, peripheral, transluminal5 reports
- SABER 48003020XCatheter, angioplasty, peripheral, transluminal4 reports
- SABER 48005004XCatheter, angioplasty, peripheral, transluminal4 reports
- SABER 48002010SCatheter, angioplasty, peripheral, transluminal3 reports
- SABER 48006002SCatheter, angioplasty, peripheral, transluminal3 reports
- SABER 48007006SCatheter, angioplasty, peripheral, transluminal3 reports
- SABER 48002504XCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48003002XCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48003515XCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48003525XCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48004006XCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48005008XCatheter, angioplasty, peripheral, transluminal2 reports
- SABER 48003025SCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48002015SCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48008010SCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48009006SCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48003504XCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48002002XCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48003506XCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48006025XCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48007006XCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48007008XCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48008006XCatheter, angioplasty, peripheral, transluminal1 report
- SABER 48002008XCatheter, 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.
MalfunctionAug 11, 2026Burst Container or Vessel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50212698 ↗MalfunctionFeb 24, 2026Leak/Splash
AS REPORTED, THE PHYSICIAN WAS USING A 6MM 15CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. AFTER HIS 4TH INFLATION IN THE PATIENT'S RIGHT LEG (CFA/SFA) THE BALLOON HAD DEVELOPED A SMALL LEAK. THIS WAS DISCOVERED WHEN THE BALLOON WAS DEFLATED AND SLIGHTLY BLOODY SALINE CAME BACK INTO THE INFLATION DEVICE THAT WE BEING USED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. AFTER BLOOD WAS OBSERVED IN THE INFLATION DEVICE, THE BALLOON WAS REMOVED AND THE PROCEDURE CONCLUDED SUCCESSFULLY, WITH THE PATIENT REMAINING STABLE. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DIFFICULTIES NOTED DURING REMOVAL FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET, OR OTHER STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE OBSERVED PRIOR TO INSERTION, AND THE DEVICE WAS PREPPED CORRECTLY, MAINTAINING NEGATIVE PRESSURE. THE INTENDED PROCEDURE TARGETED THE COMMON FEMORAL ARTERY (CFA), SUPERFICIAL FEMORAL ARTERY (SFA), AND POPLITEAL ARTERY (POP). NO RESISTANCE OR FRICTION WAS NOTED DURING INSERTION THROUGH THE ROTATING HEMOSTATIC VALVE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431573 ↗MalfunctionNov 23, 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 SABER 8MMX10CM 90 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BROKE OFF IN THE ARM AND THE DOCTOR HAD TO OPEN THE ARM TO REMOVE THE DEVICE. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION AND WAS NOT SUBJECTED TO AN ACUTE BEND DURING THE PROCEDURE. IT CROSSED THE LESION EASILY WITHOUT KINKING OR ANOMALIES DURING DELIVERY. HOWEVER, DURING A SECOND INFLATION AT 10¿12 ATMOSPHERES (ATM) WITHIN A STENTED SEGMENT, THE BALLOON RUPTURED AND COULD NOT BE RETRACTED EASILY. THE DEVICE COMPLETELY SEPARATED. A SECOND SHEATH WAS INSERTED AND THE WIRE WAS SNARED TO PREVENT MIGRATION. A SURGICAL CUTDOWN WAS PERFORMED AT THE INITIAL SHEATH ENTRY SITE, THE INITIAL SHEATH WAS REMOVED AND THE SEPARATED COMPONENTS WERE RETRIEVED FROM THE LUMEN, INCLUDING THE WIRE. THE DEVICE WAS NOT REMOVED INTACT. THE BALLOON AND MARKERS SEPARATED FROM THE INNER HYPOTUBE, WHICH ALSO DETACHED FROM THE CATHETER SHAFT. A SURGICAL CUTDOWN WAS CONFIRMED AS NECESSARY FOR REMOVAL. THE BALLOON WAS NOT CAUGHT IN THE LESION BUT WAS PROBABLY CAUGHT IN A PREVIOUSLY DEPLOYED NON-CORDIS STENT GRAFT PLACED ON (B)(6) 2012. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER OR ANY
Patient problems: Foreign Body In Patient
MAUDE report 23627670 ↗MalfunctionNov 19, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON ON A 3.5MM X 15CM SABER .018 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 8 ATMOSPHERES (ATM). A 3MM X 30CM SABER .018 PTA BALLOON CATHETER WAS THEN USED FOR SUCCESSFUL DILATION, FOLLOWED BY THE USE OF A NON-CORDIS DRUG-COATED BALLOON (DCB). THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO PERFORM RECANALIZATION OF A LOWER LIMB ARTERIAL OCCLUSION. THE TARGET VESSEL WAS THE FEMORAL-POPLITEAL ARTERY AT THE P1 SEGMENT. THE TARGET VESSEL EXHIBITED SEVERE CALCIFICATION, NO TORTUOSITY, AND 80% STENOSIS. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS NOT PLACED INTO AN ACUTE BEND AND WAS ABLE TO CROSS THE LESION WITHOUT KINKING. THE DEVICE WAS REMOVED EASILY FROM THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597046 ↗MalfunctionNov 3, 2025Leak/Splash; Leak/Splash
AS REPORTED, WHEN THE 5MM 20CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS ATTEMPTED TO BE INFLATED IT WOULD NOT HOLD PRESSURE. LEAKAGE WAS OBSERVED DURING THE PRODUCT EVALUATION. THE PROCEDURE WAS COMPLETED USING A SECOND SABER BALLOON. 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 IT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR ANY STERILE PACKAGING COMPONENTS, AND NO KINKS OR DAMAGES WERE NOTED PRIOR TO INSERTION. THE DEVICE PREPPED NORMALLY AND MAINTAINED NEGATIVE PRESSURE. HOWEVER, WHEN THE BALLOON WAS INFLATED, IT FAILED TO HOLD PRESSURE, INDICATING LEAKAGE DURING INFLATION. THE INTENDED PROCEDURE WAS A SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION. THE LESION SHOWED MODERATE CALCIFICATION, NO VESSEL TORTUOSITY, AND 85% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). A 60/40 CONTRAST-TO-SALINE RATIO WAS USED, AND THE SAME INDEFLATOR HAD BEEN USED SUCCESSFULLY WITH OTHER DEVICES DURING THE PROCEDURE. NO RESISTANCE OR FRICTION OCCURRED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, AND NO GUIDE CATHETER WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23456511 ↗MalfunctionOct 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, AN UNKNOWN GUIDEWIRE FRACTURED WHILE USING A 2.5MM X 30CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: THE DEVICE WAS RETURNED SEPARATED AT THE BALLOON PORTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321937 ↗MalfunctionSep 18, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON ON A 2.5MM X 20CM.018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST AT 16 ATMOSPHERES (ATM) ON 2.5 MM LESION. THE PROCEDURE WAS COMPLETED BY USING A REPLACEMENT SABER BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE INTENDED PROCEDURE TARGETED THE ANTERIOR TIBIAL ARTERY, WHICH EXHIBITED SEVERE CALCIFICATION AND INSUFFICIENT BLOOD SUPPLY AS THE LESION WAS A CHRONIC TOTAL OCCLUSION (CTO). THE VESSEL HAD LITTLE OR NO TORTUOSITY, WITH 85% STENOSIS. THE PRODUCT WAS STORED AND PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND THERE WERE NO ISSUES REPORTED WITH REMOVAL FROM THE HOOP, PROTECTIVE COVER, STYLET, OR STERILE PACKAGING COMPONENTS. NO DAMAGE OR KINKS WERE OBSERVED BEFORE USE, AND THE DEVICE MAINTAINING NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO RESISTANCE OR FRICTION DURING INSERTION THROUGH THE ROTATING HEMOSTATIC VALVE OR GUIDE CATHETER, NOR WERE THERE DIFFICULTIES ADVANCING THE BALLOON CATHETER OR CROSSING THE LESION. THE CATHETER WAS NOT ACUTELY BENT, AND IT DID NOT KINK DURING USE. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084801 ↗MalfunctionSep 16, 2025Leak/Splash; Leak/Splash
AS REPORTED, AFTER ADVANCING THE 3X200 SABER PERCUTNEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON INTO THE VESSEL AND APPLYING PRESSURE. THE BALLOON COULD NOT INFLATE PROPERLY. AFTER ANOTHER ATTEMPT TO PRESSURIZE, LEAKAGE WAS FOUND IN THE BALLOON. THE BALLOON WAS THEN WITHDRAWN, AND ANOTHER BALLOON OF THE SAME MODEL WAS USED TO CONTINUE THE PROCEDURE. NO OTHER SERIOUS ADVERSE OUTCOMES OCCURRED. THIS OCCURRED DURING A BELOW-THE-KNEE ARTERY PTA PROCEDURE. A 2.5X300 SABER PTA BALLOON WAS USED FIRST, WHICH WENT SMOOTHLY. THE 3X200 PTA BALLOON WAS USED FOR STEPWISE DILATATION. THE PRODUCT WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO ISSUES WERE NOTED DURING REMOVAL FROM THE HOOP, PROTECTIVE COVER, OR STERILE PACKAGING. NO DAMAGE OR KINKS WERE OBSERVED PRIOR TO INSERTION. THE INTENDED PROCEDURE WAS FOR A BELOW-THE-KNEE VESSEL OCCLUSION. THE LESION WAS MODERATELY CALCIFIED, MILDLY TORTUOUS, AND HAD A STENOSIS OF APPROXIMATELY 65¿75%. THE DEVICE WAS USED FOR TREATING A CHRONIC TOTAL OCCLUSION (CTO). THERE WERE NO DIFFICULTIES ADVANCING THE BALLOON THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NOT PLACED IN AN ACUTE BEND. THE CONTRAST TO SALINE RATIO US
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23064499 ↗MalfunctionSep 12, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, DURING INFLATION OF A 2MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO 15 ATMOSPHERES (ATM), NO BALLOON EXPANSION WAS OBSERVED. SUBSEQUENT ASPIRATION OF THE BALLOON REVEALED BLOOD WITHIN THE INDEFLATOR, 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 RIGHT ANTERIOR TIBIAL ARTERY LESION. THE TARGET VESSEL EXHIBITED MODERATE CALCIFICATION AND 80% STENOSIS. AN UNKNOWN .018 GUIDEWIRE WAS SUCCESSFULLY 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), AND NO DIFFICULTIES WERE ENCOUNTERED DURING THE REMOVAL OF THE STERILE PACKAGING. NEGATIVE PRESSURE WAS MAINTAINED DURING PREPARATION. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23039240 ↗MalfunctionSep 10, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash
AS REPORTED, A 2MM 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS THEN POSITIONED ACROSS THE LESION. DURING INFLATION USING A PRESSURE PUMP/INDEFLATOR, NO BALLOON EXPANSION WAS OBSERVED. SUBSEQUENT ASPIRATION REVEALED BLOOD WITHIN THE INDEFLATOR, CONSISTENT WITH BALLOON RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NON-CORDIS .018 BALLOON OF THE SAME SIZE. THERE WAS NO REPORTED INJURY TO THE PATIENT. AN UNKNOWN 0.018-INCH GUIDEWIRE WAS SUCCESSFULLY ADVANCED THROUGH THE POSTERIOR TIBIAL ARTERY LESION INTO THE DISTAL TRUE LUMEN. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES NOTED DURING REMOVAL FROM THE HOOP, PROTECTIVE COVER, OR STERILE PACKAGING, AND NO DAMAGE WAS OBSERVED BEFORE USE. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE PROCEDURE TARGETED A 100% STENOSED, MODERATELY CALCIFIED POSTERIOR TIBIAL ARTERY WITH NO VESSEL TORTUOSITY. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WERE NO ISSUES WITH RESISTANCE DURING INSERTION OR ADVANCEMENT, AND THE CATHETER DID NOT EXPERIENCE ACUTE BENDS OR KINKING. THE CONTRAST-TO-SALINE RATIO WAS 50%. THE DEVICE WILL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23018461 ↗MalfunctionAug 29, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn
AS REPORTED, THE 2.5MM 30CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS INTENDED TO DILATE A STENOTIC LESION, BUT AFTER ADVANCING TO A CERTAIN POSITION, IT COULD NO LONGER BE PUSHED FORWARD. UPON WITHDRAWAL OF THE SYSTEM, IT WAS FOUND THAT THE BALLOON SHAFT HAD KINKED. THE CASE WAS COMPLETED BY WITHDRAWING THE DEVICE AND USING A NON-CORDIS BALLOON. THE PRODUCT EVALUATION OBSERVED THAT THE BODY/SHAFT WAS TORN. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED AND INSPECTED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO PACKAGING DAMAGE OR DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING OR HOOP WAS REPORTED. THE DEVICE APPEARED NORMAL PRIOR TO USE, AND NO KINKS OR DAMAGE WERE OBSERVED BEFORE INSERTION. A NON-CORDIS .018 GUIDEWIRE WAS USED AND SUCCESSFULLY CROSSED THE LESION. THE TARGET LESION WAS A MODERATE STENOSIS LOCATED BELOW THE KNEE, WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. KINKS OR OTHER DAMAGE WERE NOTED AFTER THE DEVICE WAS REMOVED FROM THE PATIENT. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. NO SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING THE PROCESS. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922144 ↗MalfunctionAug 29, 2025Burst Container or Vessel; Burst Container or Vessel
A REPORTED, THERE WAS AN ISSUE WITH THE HYPOTUBE ON A 2MM X 150MM SABER .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER AND THE DEVICE WOULD NOT TRACK UP A NON-CORDIS GUIDEWIRE AND INTO THE PATIENT. RESISTANCE WAS EXPERIENCED INSIDE THE BALLOON AREA OF THE SABER .014 BALLOON CATHETER, PREVENTING IT FROM GOING ON THE WIRE NORMALLY WHEN INSERTING FROM THE DISTAL TIP. ADDITIONALLY, THERE WAS SOME DIFFICULTY FLUSHING THE GUIDEWIRE LUMEN, BUT IT WAS NOT BLOCKED WITH INJECTABLE MATERIAL. A NEW CORDIS BALLOON CATHETER WAS OPENED AND USED. THE SAME GUIDEWIRE WAS SUCCESSFULLY USED WITH THE REPLACEMENT BALLOON CATHETER WITHOUT ISSUE. LATER IN THE PROCEDURE, A 6MM X 15CM SABER PTA BALLOON CATHETER WAS OPENED; HOWEVER, THE BALLOON BURST ON CALCIUM. A NEW CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT AND THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT CHRONIC TOTAL OCCLUSION (CTO) WITH CALCIUM THROUGHOUT, THOUGH NOT SEVERE. THE SABER .014 DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE SABER .018 DEVICE WAS ALSO STORED AND PREPPED PER THE IFU, WITH NO DIFFICULTY REMOVING STERILE PACKAGING COMPONENTS. THE S
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921087 ↗MalfunctionAug 1, 2025Leak/Splash; Leak/Splash
AS REPORTED, THE BALLOON ON A 5MM X 8CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FOUND LEAKING DURING USE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. 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 22687277 ↗MalfunctionJul 8, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 5MM 25CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER .018 SABER BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE HAD BEEN STORED AND PREPARED IN ACCORDANCE WITH 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 INTENDED PROCEDURE WAS FOR THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS SEVERELY CALCIFIED. THE VESSEL TORTUOSITY WAS SEVERE. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION WITH THE BALLOON CATHETER. THE CATHETER WAS NEVER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22438042 ↗MalfunctionJun 19, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn
AS REPORTED, THERE WAS A HOLE IN THE BALLOON OF A 6MM X 20CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292734 ↗
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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