SABER 48002515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20705032069066), received between Nov 24, 2020 and Oct 22, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionApr 17, 2025Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 2.5MM X 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER NEVER FILLED PROPERLY DURING ATTEMPTED DILATION. THE DEVICE WAS WITHDRAWN FROM THE PATIENT, AND INSPECTION REVEALED AN AIR LEAK AT THE CONNECTION BETWEEN THE BALLOON AND THE DELIVERY ROD. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A LOWER EXTREMITY ARTERY INTERVENTIONAL PROCEDURE TO TREAT THE PERONEAL ARTERY BELOW THE KNEE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855374 ↗
• MalfunctionJan 26, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE PROXIMAL END OF THE BALLOON ON A 2.5MM X 15CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS BROKEN. THE PRESSURE WAS NOT MAINTAINED, AND THE PROXIMAL END OF THE BALLOON BURST. THE SHAFT DID NOT BURST, AND THE SURGEON DID NOT OBSERVE IF THE BALLOON DEFLATED NORMALLY. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURY. UPON BALLOON EXPANSION, IT WAS FOUND THAT THE BALLOON PRESSURE PUMP WAS AT NORMAL WORKING PRESSURE, BUT THE BALLOON WAS NOT SIGNIFICANTLY EXPANDED, AND THE CONTRAST AGENT WAS EXTRAVASATED FROM THE PROXIMAL END OF THE BALLOON. THE BALLOON WAS WITHDRAWN FROM THE BODY FOR DILATATION. DURING THE PROCEDURE, THE .18-INCH GUIDEWIRE WAS USED TO CROSS THE LESION, AND THE SABER BALLOON WAS TAKEN FOR FLUSHING AND THEN THE BALLOON CATHETER WAS DELIVERED TO THE LESION. THE PATIENT WAS WITHOUT INFECTIOUS DISEASE. THE DEVICE WAS USE TO TREAT THE LEFT LOWER EXTREMITY SUPERFICIAL FEMORAL TO POPLITEAL TO ANTERIOR TIBIAL ARTERIES IN A LEFT LOWER EXTREMITY ARTERY BALLOON DILATATION, STENTING, AND LEFT LOWER EXTREMITY ARTERIOGRAPHY. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21238213 ↗
• MalfunctionNov 4, 2024Leak/Splash; Leak/Splash

  AS REPORTED, THE 2.5MM 15CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON COULD NOT BE INFLATED IN THE BODY, AND CONTRAST AGENT WAS EXPOSED. AFTER THE BALLOON WAS TAKEN OUT AND INFLATED OUTSIDE THE BODY, A HOLE WAS FOUND IN THE BALLOON. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY CHANGING TO ANOTHER SABER BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES ENCOUNTERED WHEN REMOVING IT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE STYLET AND 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. HOWEVER, THE DEVICE DID NOT MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THE INTENDED PROCEDURE WAS A PTA OF THE INFERIOR PHRENIC ARTERY (IPA), WITH THE LESION BEING CALCIFIED AND EXHIBITING MILD VESSEL TORTUOSITY AND 90% STENOSIS. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THERE WAS ALSO NO DIFFICULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599985 ↗
• MalfunctionAug 28, 2023Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AS REPORTED, THE 2.5MM 15CM SABER WAS INFLATED ONCE AND THEN BURST. THE PATIENT WAS NOT HARMED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW UNKNOWN BALLOON CATH. THE SURGEON PERFORMED THE BALLOON DILATATION ON THE OCCLUDED INFRAPOPLITEAL ARTERY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE 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. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS AT THE OPENING OF THE ANTERIOR TIBIAL ARTERY WHICH HAD A STENOSIS. THE LESION WAS NOTED TO HAVE A LITTLE CALCIFICATION WITH MODERATE VESSEL TORTUOSITY. THE DEVICE WAS BEING USED TO TREAT A CHROMIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE, OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633658 ↗
• MalfunctionJun 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP END OF SABER 2.5MM 15CM BALLOON WAS FOUND TO BE BROKEN WHEN THE PACKAGE WAS OPENED DURING A VASCULAR SURGERY. THE DISTAL TIP WAS NOTED TO BE IN TWO SEPARATE PIECES. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114708 ↗
• MalfunctionJun 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHILE ADVANCING A 2.5MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WITHIN THE PATIENT, THE BODY OF THE DEVICE WAS FOUND KINKED. THE DEVICE WAS ABLE TO BE REMOVED; HOWEVER, THE DISTAL TIP WAS SEPARATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A CALCIFIED LESION IN THE LOWER EXTREMITY. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042799 ↗
• MalfunctionOct 18, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON PASSED THROUGH THE NON-CORDIS 6F SCABBARD SHEATH AND ENTERED THE PATIENT'S LOWER EXTREMITY, READY FOR EVERYTHING. THEN STUFF BEGAN TO EXPAND THE BALLOON WITH A PRESSURE PUMP, WHEN THE PRESSURE REACHED 6ATM, THE BALLOON RUPTURED LATERALLY AND THE CONTRAST AGENT LEAKED. THE RUPTURED BALLOON WAS THEN REMOVED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE DID NOT RUPTURE WHILE IN A PREVIOUSLY PLACED STENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED 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. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED DURING INSERTION OF THE DEVICE. THE DEVICE WAS ABLE TO TRACK TOWARD THE LESION AND CROSS THE LESION WITHOUT DIFFICULTY. THE LESION WAS IN THE LOWER EXTREMITY VASCULAR OPENING. THE VESSEL WAS NOTED TO HAVE MODERATE TO SEVERE STENOSIS OF THE LOWER EXTREMITY BLOOD VESSELS. THE STENOSIS WAS AT 70%. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621748 ↗
• MalfunctionSep 16, 2022Deflation Problem; Deflation Problem

  AS REPORTED, AFTER THE INITIAL INFLATION OF A 2.5MM X 15CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON WAS DIFFICULT TO ¿HOLD BACK¿. THEREFORE, AN ATTEMPT TO RE-EXPAND THE BALLOON WAS MADE; HOWEVER, THE BALLOON COULD NOT BE FULLY FILLED DURING THIS SECOND EXPANSION. AS A RESULT, THE 2.5MM X 15CM 150CM SABER PTA BALLOON CATHETER WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE IN WHICH A RETROGRADE APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY TO TREAT AN OCCLUSION OF THE LEFT TIBIAL ARTERY. PRIOR TO THE USE OF THE 2.5MM X 15CM 150CM SABER PTA, AN ANGIOGRAM WAS PERFORMED TO VISUALIZE THE LEFT TIBIAL ARTERY OCCLUSION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442165 ↗
• MalfunctionFeb 21, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER 2.5MMX15CM 150 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS "BROKEN AND HAS SMALL HOLES" AND COULD NOT BE FILLED IN PATIENT'S BODY. IT WAS FURTHER CLARIFIED THAT THE BALLOON WAS RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. IMAGE REVIEW APPEARS TO DEMONSTRATE THE BALLOON OF A BALLOON CATHETER WITH A HOLE NOTED IN THE BALLOON MATERIAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13567534 ↗
• MalfunctionNov 19, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 2.5MM X 15CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED BELOW ITS NOMINAL PRESSURE AFTER THE FIRST BALLOONING. IT WAS NECESSARY TO OPEN ANOTHER MEDICAL DEVICE (UNKNOWN) TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843663 ↗
• MalfunctionFeb 8, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 2.5MM X 15CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER RUPTURED BEFORE REACHING NOMINAL PRESSURE. THEREFORE, A NEW UNKNOWN BALLOON WAS OPENED, AND CASE RESUMED. THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR WAS TRAINED TO THE SABER BALLOON CATHETER. THE DEVICE WAS OPENED IN STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11298040 ↗
• MalfunctionDec 8, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER THE BALLOON OF A 2.5MM X 15CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER REACHED THE WORKING PRESSURE OF 8 ATMOSPHERES (ATM); THE USER CONTINUE TO PRESSURIZE TO 10 ATM AND THE BALLOON RUPTURED. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER SABER RX BALLOON CATHETER TO COMPLETE THE DILATATION OF THE LESION. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION/VESSEL WAS THE LEFT SUPERFICIAL FEMORAL ARTERY, WITH LITTLE CALCIFICATION, NO TORTUOSITY AND 100 PERCENT STENOSED. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, 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. THE DEVICE WAS OPENED IN A STERILE FIELD. THE DEVICE PREPPED NORMALLY. THE CUSTOMER USED THE BALLOON, ¿NORMAL OPERATION¿. THE DEVICE WAS USED IN-CONJUNCTION WITH A NON-CORDIS GUIDEWIRE. THE CONTRAST TO SALINE RATIO WAS 1:1. A NON CORDIS INDEFLATOR WAS USED AND WAS USED SUCCESSFULLY WITH OTHER DEV

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 10968393 ↗
• MalfunctionNov 24, 2020Leak/Splash; Leak/Splash

  AS REPORTED, A 2.5MM X 15CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DID NOT REACH 4 ATMOSPHERES (ATM). INITIALLY, DURING MATERIAL EVALUATION ON THE TABLE, ¿THE DOCTOR NOTED A PRESENCE OF SALINE SOLUTION JET IN THE DISTAL AREA OF THE DEVICE¿. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10896801 ↗

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