SABER 48002520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20705032069073), received between Feb 15, 2019 and Sep 18, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K133843); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionApr 2, 2025Leak/Splash; Leak/Splash

  AS REPORTED, IT WAS FOUND THAT THE BALLOON OF A 2.5MM X 20CM X 150 SABER 0.18 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER WAS STUCK ON NON-CORDIS GUIDEWIRE AND COULD NOT BE WITHDRAWN, SO THE SURGEON COULD ONLY WITHDRAW THE BALLOON TOGETHER WITH THE GUIDEWIRE. A NEW UNKNOWN GUIDEWIRE WAS INSERTED TO CONTINUE TREATMENT OF THE ANTERIOR TIBIAL ARTERY. A SABER 2.5 X 200MM BALLOON WAS DELIVERED TO THE LESION THROUGH THE GUIDEWIRE AND THE PRESSURE PUMP WAS USED TO FILL THE BALLOON. WHEN THE PRESSURE WAS BROUGHT UP TO THE WORKING PRESSURE, THE PRESSURE PUMP SHOWED A DROP IN THE PRESSURE VALUE. AFTER REPEATED ATTEMPTS, THE BALLOON WAS STILL LEAKING, SO THE OPERATOR REMOVED THE BALLOON AND REPLACED IT WITH A NON-CORDIS BALLOON TO COMPLETE THE DILATATION. POSTOPERATIVE ANGIOGRAPHY SHOWED THAT THE BLOOD FLOW WAS SMOOTH, ALL INSTRUMENTS WERE WITHDRAWN AND THE PATIENT WAS RETURNED TO THE WARD SAFELY AFTER USING AN OCCLUDER TO STOP THE BLEEDING. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO HAVE BEEN ADMITTED FOR DIABETIC FOOT AND UNDERWENT PTA PLUS STENTING OF THE LOWER EXTREMITY ARTERIES. THE OPERATION WAS PERFORMED THROUGH A PUNCTURE APPROACH FROM THE RIGHT FE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751160 ↗
• InjuryJul 15, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, A .018 SABER 2.5MMX20CM 150CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER HAD DIFFICULTY IN WITHDRAWING POST DILATATION USE. AFTER FURTHER INVESTIGATION, IT WAS FOUND THAT THE BALLOON SEEMED TO HAVE "DISLODGED" FROM ITS ORIGINAL POSITION AND WAS MISSING ONE OF THE MARKERS. THE MARKER WAS LEFT INSIDE THE PATIENT AND RETRIEVAL WAS NOT ATTEMPTED AS IT WAS DIFFICULT TO SEE. THE DEVICE WAS ABLE TO CROSS THE LESION, BUT NOT EASILY. THE DEVICE WAS DIFFICULT TO REMOVE AFTER INFLATION. THE DEVICE WAS REMOVED WITH THE UNKNOWN WIRE AS IT WAS NOT ABLE TO BE RETRIEVED OVER THE WIRE. THE DEVICE WAS REMOVED FROM THE PATIENT, BUT THE MARKER WAS LEFT BEHIND. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. AN ANTEGRADE APPROACH WAS USED WAS USED IN THE PROCEDURE. THE TARGET VESSEL WAS NOT HEAVILY CALCIFIED, NOT TORTUOUS AND NO ACUTE OR BIFURCATING ANGLES. THE STENOSIS WAS SEVERE NEAR THE OCCLUSION. A NON-CORDIS LONG SHEATH WAS USED TO REACH THE POPLITEAL ARTERY. ACCESSING THE TARGET VESSEL, IT WAS NOT CALCIFIED, TORTUOUS, HAD NO STENOSIS NOR BIF

  Patient problems: Foreign Body In Patient

  MAUDE report 19747263 ↗
• MalfunctionMay 26, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 2.5MM X 20CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT BE INFLATED AND SEEMED TO HAVE A HOLE. THERE WAS NO REPORTED INJURY TO THE PATIENT. AFTER PLACEMENT OF THE BALLOON WITHIN THE PATIENT, AN ATTEMPT TO INFLATE THE BALLOON WITH AN INFLATION DEVICE WAS MADE BUT THE BALLOON WOULD NOT INFLATE. TH DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014051 ↗
• MalfunctionJan 20, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABER 2.5MM 20CM RUPTURED AT 16ATM WHILE IN THE VESSEL. THE BALLOON DID NOT RUPTURE WHILE IN A STENT. THE BALLOON WAS WITHDRAWN INTACT AND REPLACED WITH A SABER (SAME SIZE) FOR DILATION. THE CASE WAS COMPLETED, AND THE PATIENT RETURNED TO THE WARD AFTER THE OPERATION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS BEING USED TO PERFORM A PTA ON THE LOWER EXTREMITY AND WAS PLACED ALONG AN UNKNOWN GUIDEWIRE. THE INTENDED LESION WAS IN THE LOWER EXTREMITY WITH ATHEROSCLEROTIC DISEASE. THE LESION WAS NOTED TO HAVE NO CALCIFICATION WITH AN 85% STENOSIS. THE VESSEL HAD LITTLE TORTUOSITY. THE DEVICE WAS BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS PREPPED NORMALLY. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214708 ↗
• InjuryNov 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AFTER THE INFLATION OF A 2.5MM X 20CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO ITS RATED BURST PRESSURE (RBP), THE DEVICE BECAME STUCK ON AN UNKNOWN GUIDEWIRE AND WAS DIFFICULT TO REMOVE. THE OPERATOR ATTEMPTED TO REMOVE THE SABER PTA BALLOON CATHETER AND THE UNKNOWN GUIDEWIRE SIMULTANEOUSLY; HOWEVER, THE DISTAL END OF THE BALLOON BROKE AND WAS UNABLE TO BE RETRIEVED FROM THE TARGET VESSEL. THIS WAS DURING A PROCEDURE TO TREAT A LESION WHICH HAD CALCIFICATION BUT SHOWED NO SIGNS OF TORTUOSITY. THE DEVICE WAS OPENED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE BALLOON WAS PREPPED WITH A 50/50 CONTRAST AND SALINE MIXTURE AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS, AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THE DEVICE WAS NEVER PUT INTO AN ACUTE BEND, IT DID NOT PASS THROUGH ANY IMPLANTED STENTS, AND THE DEVICE DID NOT KINK DURING ITS USE. THERE WAS NO DIFFICULTY DURING INFLATION OR DEFLATION OF THE BALLOON. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821356 ↗
• MalfunctionApr 5, 2021Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THE BODY OF THE BALLOON OF A 2.5MM X 20CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT FIFTEEN ATMOSPHERE (15 ATM). THERE WAS NO REPORTED PATIENT INJURY. CHANGED TO ANOTHER BALLOON OF SAME MODEL TO COMPLETE THE PROCEDURE. THE TARGET LESION IS THE LOWER LIMBS WHICH WAS CHRONIC TOTAL OCCASION WITH SEVERE CALCIFICATION AND TORTUOUS. THERE WERE NO DIFFICULTY NOTED IN THE BALLOON DURING PREP. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. A COMPETITOR'S CONTRAST MEDIA AND INFLATION DEVICE WERE USED WITH A ONE TO ONE RATIO. THE INFLATION DEVICE WAS NOT SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE CATHETER HAS NEVER BEEN IN AN ACUTE BEND. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615226 ↗
• MalfunctionNov 17, 2020Material Rupture; Material Rupture

  A 2.5MM X 20CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER BURST UPON INFLATION WITH A NON-CORDIS INFLATION DEVICE. THE BALLOON DID NOT REACH NOMINAL INFLATION OF 8 ATMOSPHERES (ATM) WHEN IT BURST AND BURST AT APPROXIMATELY 6 ATM. THE DEVICE WAS REMOVED WITH NO HARM TO PATIENT AND A SECOND BALLOON CATHETER (UNKNOWN) WAS USED SUCCESSFULLY. THE ACCESS SITE WAS THE FEMORAL. THE 50% OCCLUDED LESION IN THE ANTERIOR TIBIAL ARTERY WAS CALCIFIED BUT THERE WAS NO VESSEL TORTUOSITY. THE PROCEDURE BEING PERFORMED WAS BELOW THE KNEE ANGIOPLASTY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE FORMING TUBE AND NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH FROM THE NEEDLE. THE DEVICE PREPPED NORMALLY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. IT DID NOT KINK WHILE BEING USED AND WAS EASILY REMOVED. THE DEVICE WAS INTACT UPO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10853711 ↗
• MalfunctionDec 19, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  WHEN A CUSTOMER STARTED TO FLUSH A 2.5MM X 20CM X150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RIGHT AFTER THEY REMOVED IT FROM THE COIL DISPENSER, THERE APPEARED TO BE SOME PARTICLES THAT CAME OUT. THEY WERE NOT SURE WHAT TO MAKE OF IT AND OPENED ANOTHER BALLOON. THERE WAS NO PATIENT INJURY AND THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE DEVICE WAS OPENED IN A STERILE FIELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9495122 ↗
• MalfunctionDec 17, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 2.5MM X 20CM X 150 SABER RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED ON 14 ATMOSPHERE (ATM) PRESSURE. THE DEVICE WAS USED IN EXPANDING THE LOWER KNEE LESION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9481251 ↗
• MalfunctionOct 14, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER 2.5MM20CM 150 BALLOON WAS USED TO EXPAND THE LESION IN THE TREATMENT OF LOWER EXTREMITY ARTERIAL OCCLUSIVE DISEASE, THE BALLOON PRESSURE WAS 8 ATM, IT WAS FOUND THAT THE FORAMEN RUPTURED AT THE PROXIMAL-END OF BALLOON. THE BALLOON WAS FILLED FOR THE FIRST TIME, AND THE PATIENT WAS UNHARMED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE DEVICE WAS STORED FOR TWO WEEKS. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THE USER USED IODIXANOL CONTRAST MEDIA. THE CONTRAST TO SALINE RATIO WAS 1:1. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE PRODUCT WAS REMOVED INTACT. THE BALLOON CATHETER WAS REMOVED EASILY. THE LESION WAS THE ARTERY BELOW THE KNEE. THE LESION WAS NOT CALCIFIED AND THERE WAS NO VESSEL TORTUOSITY. THERE WAS ONE HUNDRED PERCENT STENOSIS AND THE DEVICE WAS USED FOR CHRONIC TOTAL OCCLUSION. ANOTHER SABER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188305 ↗
• MalfunctionFeb 15, 2019Structural Problem; Structural Problem

  AS REPORTED, THREE SABER 5MM6CM 150, SABER 6MM6CM 150 AND SABER 2.5MM20CM 150 BALLOONS EXPANDED PAST THE MARKER BANDS. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICES WERE RECEIVED BY THE REPRESENTATIVE THE SAME MORNING OF THE PROCEDURE. THE DEVICES WERE STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WERE NO ANOMALIES NOTED TO THE DEVICES WHEN THEY WERE TAKEN OUT OF THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE PACKAGING OR REMOVING THE PRODUCTS FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVERS. THE PRODUCTS WERE INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCTS INTO THE PATIENT. THERE WAS NO UNUSUAL FORCE USED AT ANYTIME DURING THE PROCEDURE. THE LESION WAS MODERATELY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE BALLOON DID NOT INFLATE NORMALLY. THE MAXIMUM INFLATION PRESSURE WAS NOMINAL. ALL THE MARKER BANDS WERE ACCOUNTED FOR AT THE END OF THE PROCEDURE. THE PATIENT IS DOING FINE. THE TARGET LESION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8344637 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133843. One submission often covers many models, so check the product and lot details in each record.

• Z-2235-2021 · Jul 19, 2021 · Terminated
  Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X