SABER 48002530XRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032069295), received between Oct 21, 2019 and Oct 17, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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.

• 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 ↗
• 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 ↗
• MalfunctionMay 27, 2025Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  AS REPORTED, THE SURGEON CHOSE A 2.5-300 MM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON FOR DILATION. UPON OPENING THE OUTER PACKAGING, IT WAS FOUND THAT THE STERILE PACKAGING BAG WAS ALREADY OPEN. THEREFORE, A NEW 2.5 BALLOON WAS USED FOR THE SURGERY. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087523 ↗
• MalfunctionApr 30, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING 2.5MM 30CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON INFLATION, THE BALLOON WAS FOUND TO BE UNABLE TO FILL. AN EXAMINATION OUTSIDE THE PATIENT REVEALED THE BALLOON WAS RUPTURED. THE BALLOON RUPTURED BELOW THE RATED BURST PRESSURE (RBP). THE PROCEDURE WAS COMPLETED BY SWITCHING TO ANOTHER 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 THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE STYLET AND OTHER 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 AND MAINTAINED NEGATIVE PRESSURE DURING PREP. THE INTENDED PROCEDURE WAS PRE-DILATATION OF THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS SEVERELY CALCIFIED. THE VESSEL HAD NO TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS 80%. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO). NO RESISTANCE OR FRICTION WAS ENCOUNTERED WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. NO GUIDE CATHETER WAS USED. THERE WAS DIFFICULTY CROSSING THE LESION WITH THE BALLOON CAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935396 ↗
• MalfunctionJan 20, 2023Leak/Splash; Leak/Splash

  AS REPORTED, AFTER INFLATION OF THE SABER 2.5MM 30CM BALLOON TO 10ATM, IT WAS NOTICED THAT THE BALLOON WASN¿T HOLDING ITS SIZE. IT WAS NOTED TO BE SMALLER VIA FLUOROSCOPY, THOUGH IT WASN¿T BEING DEFLATED. THE PHYSICIAN REMOVED BALLOON FROM PATIENT AND INFLATED IT OUTSIDE OF THE BODY TO CHECK FOR LEAKS. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. IT WAS OBSERVED BY MD, THE TECH, AND SALES REP, THAT THERE WAS LEAKING NOTED TOWARD THE PROXIMAL END OF THE BALLOON. THE CASE WAS COMPLETED WITH THE USE OF A NON-CORDIS BALLOON. NO HARM CAME TO PATIENT. THE PROCEDURE BEING PERFORMED WAS A LEFT LEG ANGIOGRAM, WITH ANTEGRADE APPROACH. A 5F NON-CORDIS SHEATH WAS BEING USED. THE DEVICE 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 ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INTENDED LESION WAS IN THE LEFT POSTERIOR TIBIAL ARTERY. THE LESION WAS NOTED TO HAVE NO CALCIFICATION AND NO TORTUOSITY. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215354 ↗
• MalfunctionDec 13, 2021Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON ON THE SABER 2.5MM X 30CM CATHETER WAS NOTED TO HAVE LEAKAGE FROM THE MIDDLE SECTION OF THE BALLOON. THIS WAS NOTED AFTER THE DEVICE WAS INSERTED INTO THE VESSEL AND COULD NOT BE FILLED, AFTER THIS THE BALLOON WAS REMOVED FROM FROM THE PATIENT. THE CASE WAS COMPLETED WITH A NEW CORDIS BALLOON (SAME PRODUCT). 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 THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS, OR ANY DAMAGES NOTED ON THE DEVICE PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE TARGET LESION WAS IN THE LOWER EXTREMITY WITH ARTERIOSCLEROSIS. THE LESION WAS NOTED TO HAVE NO CALCIFICATION OR TORTUOSITY; HOWEVER, THE LESION WAS NOTED TO HAVE A 75% STENOSIS. THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION. THERE WAS NO RESISTANCE/FRICTION WHILE THE BALLOON CATHETER WAS INSERTED INTO THE ROTATING HEMOSTATIC VALVE, GUIDE CATHETER, OR WHILE ADVANCING THROUGH THE VESSEL. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984662 ↗
• MalfunctionOct 19, 2020Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THEY NOTICED A HOLE PROXIMAL 5CM BEFORE THE BALLOON OF A 2.5MM X 30CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THEY NOTICED THIS WHEN THEY WERE GOING TO WET IT WITH COMPRESSION AS THEY ALWAYS DO, SO THEY DID NOT HAVE THE UNKNOWN WIRE INSIDE YET. THE PRODUCT WAS NEVER ENTERED INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS NEVER USED INSIDE THE PATIENT. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, FROM THE PROTECTIVE BALLOON COVER OR WHEN REMOVING 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. THE DEVICE WAS OPENED IN A STERILE FIELD. THE USER WAS TRAINED WITH THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10697307 ↗
• MalfunctionSep 1, 2020Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THE 2.5MM X 30CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) HAS A DEFECT ON THE SHAFT. THERE WAS A HOLE IN THE OUTER LAYER ON THE DEVICE. THE DEFECT WAS NOTED WHEN THE INNER PACKAGE WAS OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT USED FOR A PATIENT. THE DEVICE WAS OPENED IN STERILE FIELD. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THE DEVICE WILL BE RETURNED FOR ANALYSIS. IMAGE IS AVAILABLE FOR REVIEW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10476039 ↗
• MalfunctionOct 21, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING THE PROCEDURE, THE DOCTOR OBSERVED A HOLE IN THE SABER BALLOON CATHETER WHEN A LEAK APPEARED DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THERE WAS NO PATIENT INJURY. A COMPETITOR'S 0.018" GUIDE WIRE AND 6F SHEATH WAS USED. THE DEVICE IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215672 ↗

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