SABER 48005025XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032069561), received between Sep 9, 2020 and Jul 8, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM 25CM .018 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER .018 SABER BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE HAD BEEN STORED AND PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO 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. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE PREPPED NORMALLY, MAINTAINING NEGATIVE PRESSURE. THE INTENDED PROCEDURE WAS FOR THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS SEVERELY CALCIFIED. THE VESSEL TORTUOSITY WAS SEVERE. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE OR FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION WITH THE BALLOON CATHETER. THE CATHETER WAS NEVER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438042 ↗
• MalfunctionApr 3, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 5F 5MM X 200MM X 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER POPPED IN THE VESSEL UPON INFLATION OF 8ATM OF PRESSURE. THE PROCEDURE WAS COMPLETED, AND PATIENT WAS STABLE. THERE WERE NO REPORTS OF PATIENT INJURY. THIS ISSUE OCCURRED AFTER A NON-CORDIS ATHERECTOMY DEVICE WAS USED. THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS CALCIFIED. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, NOR WAS THERE DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE TARGET SITE VESSEL WAS CALCIFIED, HOWEVER THERE WAS NO TORTUOSITY AND HAD 60% STENOSIS. THERE WAS NO ACUTE ANGULATION OR BIFURCATION OF THE VESSEL. THERE WAS SOME CALCIFICATION AT THE ACCESS SITE BUT NO TORTUOSITY. THERE WAS NO STENOSIS, ACUTE ANGULATION, OR BIFURCATION OF THE ACCESS SITE VESSEL. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND AT ANY POINT DURING THE PROCEDURE. THE DEVICE WAS ABLE TO CROSS THE LESION. THE DEVICE DID NOT KINK AT ANY TIME DURING THE PROCEDURE. THERE WERE NO ANOMALIES NOTED AFTER THE DEVICE WAS DELIVERED TO THE LESION. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665237 ↗
• MalfunctionFeb 13, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM X 25CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INFLATION TO 4 ATMOSPHERES (ATM) AND WAS UNABLE TO BE FILLED. AS A RESULT, A 5MM X 22CM NON-CORDIS PTA BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT AN 80% CHRONIC TOTALLY OCCLUDED (CTO) LESION IN THE LEFT LOWER SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD CALCIFICATION AND VESSEL TORTUOSITY. 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 BALLOON WAS PREPPED WITH A 1:1 CONTRAST TO SALINE RATIO AND THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS ABLE TO BE REMOVED EASILY FORM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16364813 ↗
• MalfunctionApr 25, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 5MM X 25CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS UNABLE TO CROSS THE DISTAL END OF A LESION AND, AFTER A NORMAL INFLATION OF THE BALLOON TO NOMINAL PRESSURE, THE BALLOON WAS EXTREMELY DIFFICULT TO DEFLATE. THE BALLOON WAS EVENTUALLY DEFLATED ON ITS OWN AND WAS REMOVED EASILY FROM THE PATIENT IN ONE PIECE. ANOTHER 5MM X 25CM 150CM SABER PTA BALLOON CATHETER FROM A DIFFERENT LOT WAS USED IN PLACE OF THE INITIAL SABER PTA BALLOON CATHETER; HOWEVER, DURING AN INFLATION TO NOMINAL PRESSURE, THE BALLOON OF THE SECOND 5MM X 25CM 150CM SABER PTA BALLOON CATHETER RUPTURED. THE RUPTURED 5MM X 25CM 150CM SABER PTA BALLOON CATHETER WAS THEN REMOVED AND A 5MM X 20CM SABER PTA BALLOON CATHETER WAS USED WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A CALCIFIED LESION IN WHICH A NON-CORDIS .014 GUIDEWIRE WAS USED AND THERE WAS NO OBSERVED DAMAGE TO THIS GUIDEWIRE. BOTH OF THE 5MM X 25CM 150CM SABER PTA BALLOON CATHETERS WERE STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICES FROM THEIR HOOP, REM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192187 ↗
• MalfunctionApr 25, 2022Deflation Problem; Deflation Problem

  AS REPORTED, A 5MM X 25CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS UNABLE TO CROSS THE DISTAL END OF A LESION AND, AFTER A NORMAL INFLATION OF THE BALLOON TO NOMINAL PRESSURE, THE BALLOON WAS EXTREMELY DIFFICULT TO DEFLATE. THE BALLOON WAS EVENTUALLY DEFLATED ON ITS OWN AND WAS REMOVED EASILY FROM THE PATIENT IN ONE PIECE. ANOTHER 5MM X 25CM 150CM SABER PTA BALLOON CATHETER FROM A DIFFERENT LOT WAS USED IN PLACE OF THE INITIAL SABER PTA BALLOON CATHETER; HOWEVER, DURING AN INFLATION TO NOMINAL PRESSURE, THE BALLOON OF THE SECOND 5MM X 25CM 150CM SABER PTA BALLOON CATHETER RUPTURED. THE RUPTURED 5MM X 25CM 150CM SABER PTA BALLOON CATHETER WAS THEN REMOVED AND A 5MM X 20CM SABER PTA BALLOON CATHETER WAS USED WITHOUT ISSUE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A CALCIFIED LESION IN WHICH A NON-CORDIS .014 GUIDEWIRE WAS USED AND THERE WAS NO OBSERVED DAMAGE TO THIS GUIDEWIRE. BOTH OF THE 5MM X 25CM 150CM SABER PTA BALLOON CATHETERS WERE STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICES FROM THEIR HOOP, REM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192178 ↗
• MalfunctionApr 23, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABER 5MM25CM 150 RUPTURED BELOW BURST PRESSURE WHILE IN THE VESSEL. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE BALLOON WAS NOTED TO RUPTURE BELOW RBP WHILE IN THE VESSEL. THE BALLOON DID NOT RUPTURE WHILE IN A STENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INTENDED PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS NOTED TO BE CALCIFIED. THE VESSEL DID NOT HAVE ANY TORTUOSITY. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE DEVICE THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE CATHETER ADVANCED THROUGH THE VESSEL WITHOUT DIFFICULTY. THE DEVICE CROSSED THE LESION WITHOUT DIFFICULTY. THE CATHETER WAS NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191020 ↗
• MalfunctionMar 23, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MMX 25CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INFLATION TO 14 ATMOSPHERES (ATM). AS A RESULT, THE SABER PTA BALLOON CATHETER WAS REMOVED AND A 5MM X 20CM NON-CORDIS BALLOON CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT ARTERIOSCLEROSIS OBLITERANS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION IN THE SFA WAS REPORTED AS A LONG SEGMENT STENOSIS OF 90% WHICH WAS CONFIRMED TO BE A FUNCTIONAL CHRONIC TOTAL OCCLUSION (CTO). THERE WAS CALCIUM PRESENT AT THE TARGET LESION; HOWEVER, THERE WERE NO SIGNS OF TORTUOSITY TO THE SFA. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION AND THERE WERE NO KINKS OR OBSERVED DAMAGES NOTED PRIOR TO INSERTION. A NON-CORDIS .018 GUIDEWIRE WAS USED FOR THE PROCEDURE. THERE WERE NO DAMAGES OBSERVED ON THE .018 GUIDEWIRE AND THE WIRE WAS SUCCESSFULLY DELIVERED TO THE LESION FOLLOWED BY THE INSERTION OF THE SABER PTA BALLOON CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13863450 ↗
• MalfunctionSep 9, 2020Material Rupture; Material Rupture

  DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA, THE PROXIMAL TIP OF A 5MM X 25CM X 150CM SABER PTA BALLOON CATHETER LEAKED DURING INFLATION AND THE BALLOON BURST AFTER A MAXIMUM INFLATION WAS 8 ATMOSPHERES (ATM). THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER BALLOON. THE 60% OCCLUDED LESION IN THE WAS MODERATELY CALCIFIED WITH NO VESSEL TORTUOSITY. THE ACCESS SITE WAS THE FEMORAL ARTERY. THE PROCEDURE BEING PERFORMED WAS A FEMORAL ARTERY STENOSIS OPENING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE FORMING TUBE, NO DIFFICULTY REMOVING THE PROTECTIVE SHEATH FROM THE NEEDLE AND NO DIFFICULTY REMOVING 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 PREPPED NORMALLY. THE CONTRAST USED WAS BY GE WITH A MERIT INFLATION DEVICE, AT A 1:1 CONTRAST TO SALINE RATIO. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND NO DIFFICULTY CROSSING THE LESION. THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507290 ↗

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