SABER 48004030XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032069509), received between Dec 12, 2019 and Jun 27, 2025 — classified as 3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A 4MM X 30CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INFLATION TO 8 ATMOSPHERES (ATM). WHEN ATTEMPTING TO REMOVE THE BALLOON THROUGH A NON-CORDIS 5F 45CM SHEATH, THERE WAS RESISTANCE, AND THE NON-CORDIS SHEATH HAD TO BE REMOVED WITH THE SABER PTA BALLOON CATHETER AS A UNIT. A NEW NON-CORDIS 5F 45CM SHEATH WAS PLACED AND THE PROCEDURE WAS COMPLETED WITH A NON-CORDIS .014 - 6X240 BALLOON CATHETER. THERE WERE NO ADVERSE EVENTS OR REPORTED PATIENT INJURIES. THIS WAS DURING A PROCEDURE TO TREAT AN IN-STENT RESTENOSIS (ISR) OF A NON-CORDIS STENT WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA) IN WHICH LASER ATHERECTOMY WAS INITIALLY PERFORMED. THE TARGET SITE VESSEL HAD MILD TORTUOSITY AND A STENOSIS PERCENTAGE OF 90% TO 100% WITH NO CALCIFICATION. THE SABER PTA BALLOON CATHETER WAS USED POST ATHERECTOMY AND WAS SUCCESSFULLY INFLATED ONCE TO 12 ATM. THE DEVICE WAS THEN DEFLATED AND REPOSITIONED FOR A SECOND INFLATION WHICH IS WHEN THE BURST OCCURRED. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE CONTRAST TO SALINE MIXTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344762 ↗
• MalfunctionMay 3, 2024Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 4MM X 30CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FOUND LEAKING DURING POSITIVE PRESSURE. A NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 90% STENOSED LOWER LIMB ARTERY WHICH HAD MODERATE CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED WITH A 50/50 CONTRAST AND SALINE MIXTURE. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238166 ↗
• MalfunctionDec 12, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 4 X 300MM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 13 ATM (ATMOSPHERES) WHILE TREATING A LESION IN THE POPLITEAL AND DISTAL SUPERFICIAL ARTERY (SFA). THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE DEVICE WAS STORED IN THE CATH LAB FOR APPROXIMATELY 12 MONTHS AS PER INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS STORED, HANDLED AND PREPPED AS PER IFU. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAINED NEGATIVE PRESSURE). THERE WAS LITTLE TORTUOSITY NOTED ON THE VESSEL. IT HAD 90% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THERE WAS NO DIFFICULTY IN REMOVING THE STYLET OR ANY STERILE PACKAGING COMPONENTS. THERE WAS NO DIFFICULTY IN REMOVING PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY IN REMOVING THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. A NON-CORDIS CONTRAST MEDIA WAS USED AND THE CONTRAST TO SALINE RATIO IS 50/50. THEY USED A NON-CORDIS INFLATION DEVICE (INDEFLATOR/SYRINGE) AND THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION FELT WHILE INSERTING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9458777 ↗

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