SABER 48006020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20705032069639), received between Feb 25, 2019 and Jun 19, 2025 — classified as 2 injuries, 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THERE WAS A HOLE IN THE BALLOON OF A 6MM X 20CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292734 ↗
• InjuryFeb 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DISTAL TIP OF A 6MM X 20CM150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON SEPARATED INSIDE THE PATIENT. THE USER DID NOT NOTICE THE BROKEN CATHETER DISTAL TIP WHILE USING THE BALLOON CATHETER; HOWEVER, LATER DURING THE PROCEDURE, ASPIRATION WAS REQUIRED, AND THE DISTAL END OF THE SABER BALLOON CATHETER WAS RETRIEVED. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS REPORTED TO BE A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THERE WAS MODERATE VESSEL TORTUOSITY AND CALCIFICATION. THE PERCENTAGE STENOSIS IS UNKNOWN; IT IS ALSO UNKNOWN IF THE DEVICE WAS BEING USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER NOR DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON INTO THE PATIENT OR DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL NOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16350773 ↗
• MalfunctionMay 13, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 6MM X 20CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INFLATION TO 12 ATMOSPHERES (ATM) WHILE BEING USED TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). AS A RESULT, THE 6MM X 20CM 150CM SABER PTA BALLOON CATHETER WAS REMOVED, AND A NEW 6MM X 20CM 150CM SABER PTA BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A RIGHT SFA LESION WHICH HAD A 70% STENOSIS AND THE PRESENCE OF CALCIFICATION. THE TARGET VESSEL WAS NOT TORTUOUS AND THERE WERE NO SIGNS OF A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. A 50/50 CONTRAST AND SALINE MIXTURE WAS USED TO PREP THE BALLOON. 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 BALLOON CAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14395209 ↗
• MalfunctionFeb 1, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 6MM X 20CM X 150CM SABER BALLOON CATHETER (BC) WAS USED, BUT IT WAS FOUND THAT THE BALLOON WAS RUPTURED POINTEDLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262493 ↗
• InjuryMar 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON DETACHED FROM A SABER 6MM20CM 150 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND EMBOLIZED DOWN TO THE TIBIOPERONEAL (TP) TRUNK. THE BALLOON SOMEHOW ATTACHED TO THE UNKNOWN GUIDEWIRE AND WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ISSUE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897709 ↗
• MalfunctionFeb 25, 2019Leak/Splash; Leak/Splash

  AS REPORTED BY THE SALES REP, A LEAKAGE OF THE BALLOON ON THE 6MMX20CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS NOTED, AND UPON REMOVAL FROM THE PATIENT, THE BALLOON WAS INFLATED AND A PINHOLE WAS CONFIRMED, LIKELY CAUSED BY A HIGHLY CALCIFIED TARGET VESSEL. NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS OBESE. THE VESSEL WAS SEVERELY CALCIFIED AND WAS A CHRONIC TOTAL OCCLUSION (CTO) OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NOT TORTUOUS. THE DEVICE WAS PREPPED AND STORED PER THE INSTRUCTIONS FOR USE (IFU), AND IT PREPPED NORMALLY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, AND NO DIFFICULTY REMOVING THE 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 NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. THE CONTRAST MEDIA USED WAS OMNIPAQUE AND THE CONTRAST TO SALINE RATIO WAS 50/50. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND THE CATHETER WAS POSSIBLY IN AN ACUTE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8365879 ↗

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