Saber .035Recalls & reported problems across all models
Cordis Corporation · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 21 models of Saber .035 by Cordis Corporation in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Dec 17, 2021 and Jan 9, 2026 — classified as 3 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (14 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 .035 problems
Device problems
- Burst Container or Vessel14
- Detachment of Device or Device Component5
- Deflation Problem3
- Leak/Splash3
- Difficult to Remove2
- Defective Component1
- Device Contamination with Chemical or Other Material1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
Saber .035 models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Saber .035 48007004NCatheter, angioplasty, peripheral, transluminal3 reports
- Saber .035 48007020RCatheter, angioplasty, peripheral, transluminal2 reports
- Saber .035 48010004NCatheter, angioplasty, peripheral, transluminal2 reports
- Saber .035 48007010RCatheter, angioplasty, peripheral, transluminal2 reports
- Saber .035 48005015RCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48005004RCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48006002NCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48004030RCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48007004RCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48006030RCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48008006RCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48008010NCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48009004NCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48005020RCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48012004NCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48005010RCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48012004RCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48005008NCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48006012RCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48006006RCatheter, angioplasty, peripheral, transluminal1 report
- Saber .035 48010008RCatheter, angioplasty, peripheral, transluminal1 report
Recent Saber .035 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2026Burst Container or Vessel
AS REPORTED, DURING AN ATTEMPT TO INFLATE THE BALLOON ON A 5MM X 100MM SABER .035 PERCUTANEOUS TRANSLATION ANGIOPLASTY (PTA) BALLOON CATHETER USING A PRESSURE PUMP WAS UNSUCCESSFULLY. AFTER REMOVING THE DEVICE, IT WAS FOUND TO HAVE RUPTURED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A MINIMALLY INVASIVE DIRECT ANGIOPLASTY. ADDITIONAL DETAILS ARE NOT AVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24020774 ↗MalfunctionDec 15, 2025Deflation Problem; Deflation Problem
AS REPORTED, THE BALLOON OF A .035-INCH 7X200 135CM SABER .035 PTA DILATATION CATHETER WOULD NOT DEFLATE AFTER INFLATION TO NOMINAL PRESSURE. THE OPERATOR REMOVED THE .014 WIRE, LOSING WIRE ACCESS, AND INSERTED A .035 WIRE THROUGH THE LUMEN, AFTER WHICH THE BALLOON SLOWLY DEFLATED AND THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE HAD BEEN OPENED AND PREPARED IN THE STERILE FIELD PER THE INSTRUCTIONS FOR USE, WAS ADVANCED OVER A CORDIS ATW GUIDEWIRE TO THE TARGET LESION, AND RESISTANCE WAS FELT WHEN THE .035 WIRE WAS INSERTED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802616 ↗InjuryDec 12, 2025Deflation Problem; Deflation Problem
AS REPORTED, AFTER BALLOON INFLATION OF A 7MM X 200MM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO NOMINAL PRESSURE FOR 30 SECONDS, THE OPERATOR ATTEMPTED TO DEFLATE THE BALLOON; HOWEVER, IT WOULD NOT DEFLATE. THE OPERATOR REMOVED THE INFLATION DEVICE AND ATTACHED A 20CC SYRINGE TO THE LUER HUB TO ATTEMPT TO DEFLATE BUT DEFLATION WAS UNSUCCESSFUL. THE OPERATOR DECIDED TO CUT AND REMOVE THE LUER HUB. AFTER SOME TIME, THE BALLOON SLOWLY DEFLATED AND WAS SAFELY REMOVED. AN 7MM X 200MM SABER .035 PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THE DEVICE WAS OPENED AND PREPPED IN THE STERILE FIELD PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS INSERTED THROUGH AN UNKNOWN SHEATH AND OVER A 300CM STRAIGHT TIP FLOPPY ALL TRACK WIRE (ATW) GUIDEWIRE. AFTER INSERTION OF THE .014 GUIDEWIRE, THE WIRE WAS NOT EXCHANGED FOR AN .035 GUIDEWIRE BEFORE INFLATION, AND THE SABER .035 BALLOON CATHETER WAS INFLATED OVER THE .014 GUIDEWIRE. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23788394 ↗MalfunctionNov 19, 2025Deflation Problem; Deflation Problem
AS REPORTED, THE BALLOON OF A 6MM X 20MM SABER .035 80CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT BE DEFLATED AFTER SUCCESSFUL DILATION. DESPITE MULTIPLE ATTEMPTS USING A NON-CORDIS INFLATION/DEFLATION DEVICE, DEFLATION COULD NOT BE ACHIEVED. AFTER MULTIPLE ATTEMPTS AND REPEATED MANEUVERS USING BOTH THE UNKNOWN SHEATH AND THE INFLATION/DEFLATION DEVICE WAS THE BALLOON FINALLY ABLE TO DEFLATE. NO HARM OCCURRED TO THE PATIENT AND THERE WERE NO REPORTED PATIENT INJURIES. THIS WAS DURING AN INTERVENTIONAL PROCEDURE. 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 23597881 ↗MalfunctionOct 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THREE 7MM X 40MM 80CM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETERS WERE USED DURING A PROCEDURE. THE FIRST SABER .035 PTA BALLOON CATHETER HAD GREAT DIFFICULTY PASSING OVER A 175CM .035 EMERALD J- TIP GUIDEWIRE AND THE GUIDEWIRE WAS STUCK AT THE HUB. THE PROTECTIVE SHEATH ON THE SECOND SABER .035 PTA BALLOON CATHETER DID NOT COME OFF THE BALLOON AND THE BALLOON WAS DISLODGED FROM THE CATHETER WITH CONSIDERABLE FORCE. THE THIRD SABER .035 BALLOON CATHETER ALSO HAD DIFFICULTY DISLODGING FROM THE BALLOON PORTION AND THERE WAS FRICTION EXPERIENCED DURING PREPARATION. THE RESISTANCE/FRICTION WAS EXPERIENCED BETWEEN THE BALLOON CATHETER AND THE EMERALD GUIDEWIRE, AS IT DID NOT MOVE SMOOTHLY OVER THE CATHETER; THEREFORE, THE DOCTOR DECIDED NOT TO USE THE DEVICE FURTHER IN THE PROCEDURE DUE TO CONCERN IT COULD BECOME STUCK IN THE PATIENT. NONE OF THE THREE DEVICES WERE INSERTED INTO THE PATIENT AND AN UNKNOWN BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A PROCEDURAL DELAY, HOWEVER; THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICES WERE STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). REGARDING THE FIRST SABER .035 PTA BALLOO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23323039 ↗MalfunctionSep 15, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, A 7X40 .035 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED AT NOMINAL PRESSURE AFTER BEING INFLATED INSIDE OF A STENT. THE BALLOON RUPTURED BELOW THE RATED BURST PRESSURE (RBP). THE PROCEDURE WAS COMPLETED WITH POST-DILATATION USING A SABER .035 PTA BALLOON. NO HARM OR INJURY OCCURRED TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU). THE BALLOON WAS REMOVED FROM THE HOOP, PROTECTIVE COVER, AND STERILE PACKAGING WITHOUT DIFFICULTY. THERE WERE NO KINKS OR DAMAGES WERE NOTED PRIOR TO INSERTION. THE DEVICE WAS PREPPED ACCORDING TO THE IFU AND MAINTAINED NEGATIVE PRESSURE NORMALLY. THE INTENDED PROCEDURE TARGETED A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA), WHICH WAS SEVERELY CALCIFIED WITH NO VESSEL TORTUOSITY AND 70¿80% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). NO RESISTANCE OR FRICTION OCCURRED DURING INSERTION THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE ADVANCING THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NOT IN AN ACUTE BEND AND DID NOT KINK DURING USE. A 50/50 CONTRAST-TO-SALINE RATIO WAS USED. THE AFFECTED UNIT WAS DISCARDED BY THE STAFF POST PROCEDURE AND IS N
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23054843 ↗MalfunctionMay 13, 2025Leak/Splash; Leak/Splash
AS REPORTED, WHEN FLUSHING A 7MM X 100MM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WITH A SYRINGE, SALINE SQUIRTED OUT OF THE PROXIMAL PORTION OF THE BALLOON. AN UNKNOWN BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED A LEAKAGE THROUGH THE BODY/SHAFT OF THE SABER PTA BALLOON CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22013425 ↗MalfunctionApr 21, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 4MM X 300MM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BEFORE REACHING BURST PRESSURE. THERE WERE NO REPORTED INJURIES 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 21875396 ↗MalfunctionMar 31, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 10MM X 80MM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT BE INFLATED AND THERE WAS CONTRAST EXPOSED. AFTER REMOVING THE DEVICE FROM THE PATIENT, THE BALLOON WAS FILLED AND A RUPTURE HOLE IN THE BALLOON WAS FOUND. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A DILATATION OF THE COMMON ILIAC ARTERY IN A PROCEDURE TO TREAT A LOWER EXTREMITY ARTERIAL OCCLUSION. THE TARGET SITE VESSEL CHARACTERISTICS WERE SEVERE CALCIFICATION, NO TORTUOSITY, AND 80% STENOSIS. 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 1:1. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21732141 ↗InjuryMar 10, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
AS REPORTED, A 6 MM X 60 MM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS OPENED AND USED FOR PTA IN THE RIGHT EXTERNAL ARTERY AT 10 ATMOSPHERES (ATM) FOR 30 SECONDS. A NON-CORDIS STENT WAS PLACED AND THE SAME 6 MM X 60 MM SABER .035 PTA BALLOON CATHETER WAS USED TO POST DILATE THE STENT IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AT 12 ATM FOR 15 SECONDS WHEN A BALLOON RUPTURE OCCURRED. WHEN THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT, THE BALLOON WAS NOT INTACT. HALF OF THE BALLOON AND THE ENTIRE DELIVERY SHAFT THAT RUNS THROUGH THE BALLOON PORTION WAS LEFT IN THE PATIENT. THE SEPARATED BALLOON WAS SNARED, AND ONE RADIOPAQUE BALLOON MARKER WAS ABLE TO BE SNARED INTO AN UNKNOWN SHEATH. HOWEVER, THE OTHER RADIOPAQUE BALLOON MARKER WAS LEFT IN THE RIGHT COMMON FEMORAL ARTERY AND WAS UNABLE TO BE RETRIEVED. NO ADDITIONAL INTERVENTION WAS PERFORMED AFTER ATTEMPTS TO SNARE THE SEPARATED SEGMENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE CONTRAST TO SALINE RATIO WAS 60% SALINE AND 40% CONTRAST. THE TARGET VESSEL WAS SEVERELY CALCIFIED, NOT TORTUO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21559482 ↗MalfunctionFeb 3, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 5MM X 40MM 135CM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING A PERIPHERAL PROCEDURE. ADDITIONALLY, A 6MM X 6CM SABER .018 PTA BALLOON CATHETER WAS USED, BUT THE BALLOON RUPTURED IN TWO PIECES. THE DEVICES WERE ABLE TO BE REMOVED EASILY FROM THE PATIENT. AN UNKNOWN SNARING DEVICE WAS USED TO RETRIEVE THE SEPARATED BALLOON, BUT IT WAS NOT SUCCESSFUL. OTHER UNKNOWN BALLOONS WERE USED DURING THIS PROCEDURE. THIS WAS DURING A PROCEDURE TO TREAT A LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) LESION WHICH WAS TORTUOUS. THE DEVICES WERE "RESTORED" PROPERLY PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO ISSUES REMOVING THE STERILE PACKAGING. THE DEVICES MAINTAINED NEGATIVE PRESSURE DURING PREPARATION AND WERE PREPPED WITH A 60% CONTRAST AND 40% SALINE MIXTURE. BOTH DEVICES WERE INFLATED TO 8 ATMOSPHERES (ATM). THE DEVICES WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21291813 ↗MalfunctionDec 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, PRIOR TO THE PROCEDURE, A HAIR WAS FOUND INSIDE OF THE PACKAGING FOR AN 8MM X 60MM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THE DEVICE WAS NOT USED AND THERE WERE NO REPORTED INJURIES TO THE PATIENT. 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 20925390 ↗MalfunctionDec 9, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 10X40 .035 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS OPENED AND PREPPED IN STERILE FIELD AS PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT INSERTED THROUGH AN UNKNOWN SHEATH TO TARGET LESION. THE PHYSICIAN PERFORMED HAND INFLATION AND PTA BALLOON BURST. THE PRODUCT WAS DISCARDED AND ADDITIONAL PTA BALLOON USED TO FINISH CASE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20880433 ↗MalfunctionDec 9, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, TWO .035 7X40 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOONS BURST WHILE HAND INFLATION WAS BEING PERFORMED. THE PTA BALLOONS WERE REMOVED AND ADDITIONAL THIRD BALLOON WAS USED AT LESION. THE THIRD BALLOON WAS USED TO FINISH THE CASE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS OPENED AND PREPPED IN THE STERILE FIELD PER THE INSTRUCTIONS FOR USE (IFU). THE BALLOONS WERE INSERTED THROUGH THE UNKNOWN SHEATH AND ADVANCED TO THE TARGET LESION. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20880257 ↗MalfunctionDec 9, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, TWO .035 7X40 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOONS BURST WHILE HAND INFLATION WAS BEING PERFORMED. THE PTA BALLOONS WERE REMOVED AND ADDITIONAL THIRD BALLOON WAS USED AT LESION. THE THIRD BALLOON WAS USED TO FINISH THE CASE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS OPENED AND PREPPED IN THE STERILE FIELD PER THE INSTRUCTIONS FOR USE (IFU). THE BALLOONS WERE INSERTED THROUGH THE UNKNOWN SHEATH AND ADVANCED TO THE TARGET LESION. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20880068 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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