SABER 48005020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032069554), received between May 9, 2019 and Nov 3, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 9, 2024Leak/Splash; Leak/Splash

  AS REPORTED, LEAKAGE WAS DETECTED WHEN INFLATING THE BALLOON OF A 5MM X 20CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. AN UNKNOWN DEVICE WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT OR SIGNS OF INFECTIOUS DISEASE. THIS WAS DURING A BALLOON DILATATION OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED A LEAKAGE ON THE BODY/SHAFT OF THE SABER PTA BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20884825 ↗
• InjuryJun 19, 2023Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, 5MM 20CM SABER .018 WAS PUT IN A HEAVILY CALCIFIED ARTERY THAT WAS TREATED WITH A NON-CORDIS ROTABLATOR. UPON SECOND INFLATION, THE BALLOON RUPTURED ON THE CALCIUM. THE ATMS ARE UNKNOWN. THE BALLOON WAS THEN BEING REMOVED OVER A WIRE WHEN IT MAY HAVE GOT CAUGHT ON CALCIUM. WHEN BALLOON WAS PULLED OUT, THE SCRUB TECH NOTICED THE DISTAL PART OF BALLOON WAS STILL IN THE SFA. THE BALLOON FRAGMENT WAS NOT REMOVED FROM THE VESSEL, IT WAS STENTED ACROSS. THE PATIENT WAS TAKEN TO THE HOSPITAL AND SURGERY WAS DONE BECAUSE THE PATIENT¿S VESSEL HAD THROMBOSED AFTER. IT IS BELIEVED TO BE DUE TO SOME OF THE BALLOON FRAGMENT STILL STICKING IN SFA AND PARTIALLY OCCLUDING AND SLOWING THE FLOW. IT IS UNKNOWN WHAT WAS DONE DURING SURGERY; HOWEVER, THE PATIENT IS CURRENTLY DOING WELL AND HER SFA IS OPEN AND HAS BLOOD FLOW. THE BALLOON WAS STORED PROPERLY ACCORDING TO THE IFU AND IT WAS PREPPED CORRECTLY AS WELL. THE PATIENT WAS KNOWN TO HAVE HEAVILY CALCIFIED ARTERIES. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17154981 ↗
• MalfunctionMay 25, 2023Deflation Problem; Deflation Problem

  AS REPORTED, THE FIRST SABER 6 X 20 BALLOON WAS STUCK ON THE UNKNOWN WIRE. MULTIPLE FLUSHES DID NOT SOLVE PROBLEM. A SECOND SABER 5 X20 DID NOT DEFLATE AFTER INITIAL INFLATION. DR. HAD TO PULL INTO SHEATH WITH NEGATIVE PRESSURE TO GET BALLOON OUT. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, BOTH WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004192 ↗
• MalfunctionApr 21, 2023Deflation Problem; Deflation Problem

  AS REPORTED, THE BALLOON OF A 5MM X 20CM X 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WOULD NOT DEFLATE. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784649 ↗
• MalfunctionApr 10, 2023Partial Blockage; Partial Blockage

  AS REPORTED, THAT THE 5MM 20CM SABER BALLOON CANNOT PASS THE UNKNOWN 0.018 "GUIDE WIRE. THE CASE WAS COMPLETED WITH AN UNKNOWN CORDIS BALLOON. THE NEW BALLOON WOULD NOT ADVANCE OVER THE SAME .018 WIRE. A NEW .018 WIRE FROM OTHER MANUFACTURER WAS USED AND IT PASSED. THE GUIDEWIRE WAS NOTED TO HAVE ONLY BEEN ABLE TO PASS HALFWAY THROUGH THE BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS PREPPED PER THE IFU WITH NO DIFFICULTY NOTED. THE INNER STYLET WAS REMOVED. THE FEMORAL ARTERY WAS USED FOR ACCESS SITE. THE SUPERFICIAL FEMORAL ARTERY WAS THE INTENDED TARGET SITE. A 6F NON-CORDIS SHEATH WAS USED WITH A NON-CORDIS .018 GUIDEWIRE. THERE WAS NO RESISTANCE WHILE ADVANCING THROUGH THE SHEATH. UNUSUAL FORCE WAS NOT USED AT ANY TIME DURING THE PROCEDURE. THE TARGET SITE WAS NOTED TO HAVE CALCIFICATION WITH A 70% STENOSIS. THERE WAS NO VESSEL TORTUOSITY. THE DEVICE WAS NO BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WILL NOT BE RETURNED FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707648 ↗
• MalfunctionNov 16, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF THE 5MM X 20CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. ANOTHER UNKNOWN BALLOON WAS USED TO COMPLETED THE PROCEDURE. THE TARGET LESION IS THE SUPERFICIAL FEMORAL ARTERY (SFA) 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 WAS USED. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THE PRODUCT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE IS AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10845982 ↗
• MalfunctionJan 24, 2020Burst Container or Vessel; Burst Container or Vessel

  A 5MM X 20CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED AT ITS NOMINAL PRESSURE. THEREFORE, ANOTHER SABER BALLOON CATHETER WAS OPENED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE PLUNGER DID NOT DEPRESS INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. THE MAXIMUM INFLATION PRESSURE WAS WITHIN NOMINAL PRESSURE. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SABER BALLOON CATHETER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9626865 ↗
• MalfunctionMay 9, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER PTA BALLOON CATHETER (5MM20CM 150) RUPTURED DURING DILATATION OF A CALCIFIED VESSEL. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICE WAS ACCIDENTALLY THROWN AWAY AFTER THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596354 ↗

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