SABERX .014 PTA Dilatation Catheter 47512015MRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032089811), received between May 15, 2025 and Mar 18, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (8 reports).

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 18, 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.

• MalfunctionMar 18, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 1.25MM X 15MM SABERX .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED ON ITS FIRST INFLATION TO 8 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED FROM THE PATIENT, AND A NON-CORDIS DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A HIGHLY CALCIFIED ANTERIOR TIBIAL ARTERY (ATA) OCCLUSION VIA AN IPSILATERAL ANTEGRADE APPROACH. THE TARGET VESSEL WAS NOT TORTUOUS AND EXHIBITED 100% STENOSIS. THE SABERX .014 BALLOON CATHETER WAS BEING USED FOR PRE-DILATION. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION, AND A 2:1 CONTRAST TO SALINE RATIO WAS USED. THE DEVICE WAS NOT PUT INTO AN ACUTE BEND, WAS ABLE TO CROSS THE LESION, DID NOT KINK DURING THE PROCEDURE, AND WAS REMOVED EASILY FROM THE PATIENT. THE PRODUCT WAS REMOVED INTACT IN ONE PIECE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627774 ↗
• MalfunctionJan 16, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 1.25MM X 15MM SABERX .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT APPROXIMATELY 7 ATMOSPHERES (ATM) DURING DILATION OF THE DORSALIS PEDIS ARTERY. ANOTHER 1.25MM X 15MM SABERX .014 PTA BALLOON CATHETER WAS USED; HOWEVER, THE BALLOON RUPTURED AGAIN AT APPROXIMATELY 13 ATMOSPHERES (ATM). A NON-CORDIS 1.5MM BALLOON CATHETER WAS THEN USED AS A REPLACEMENT AND WAS ABLE TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT STENOSIS OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA), THE ANTERIOR TIBIAL ARTERY, AND THE DORSALIS PEDIS ARTERY. THE TARGET VESSEL WAS CHARACTERIZED BY MODERATE TO SEVERE CALCIFICATION, MODERATE TORTUOSITY, AND 100% STENOSIS. AN UNKNOWN 6F GUIDE SHEATH WAS INSERTED FROM THE LEFT GROIN, AND AN UNKNOWN .014 GUIDEWIRE WAS USED TO CROSS THE LESION. THE DEVICES WERE STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING ANY STERILE PACKAGING COMPONENTS OR PROTECTIVE BALLOON COVERS. THE DEVICES MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. BOTH SABERX .014 PTA BALLOON CATHETERS WERE ABLE TO CROSS THE LESION PRIOR TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093839 ↗
• MalfunctionJan 16, 2026Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 1.25MM X 15MM SABERX .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT APPROXIMATELY 7 ATMOSPHERES (ATM) DURING DILATION OF THE DORSALIS PEDIS ARTERY. ANOTHER 1.25MM X 15MM SABERX .014 PTA BALLOON CATHETER WAS USED; HOWEVER, THE BALLOON RUPTURED AGAIN AT APPROXIMATELY 13 ATMOSPHERES (ATM). A NON-CORDIS 1.5MM BALLOON CATHETER WAS THEN USED AS A REPLACEMENT AND WAS ABLE TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT STENOSIS OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA), THE ANTERIOR TIBIAL ARTERY, AND THE DORSALIS PEDIS ARTERY. THE TARGET VESSEL WAS CHARACTERIZED BY MODERATE TO SEVERE CALCIFICATION, MODERATE TORTUOSITY, AND 100% STENOSIS. AN UNKNOWN 6F GUIDE SHEATH WAS INSERTED FROM THE LEFT GROIN, AND AN UNKNOWN .014 GUIDEWIRE WAS USED TO CROSS THE LESION. THE DEVICES WERE STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DIFFICULTY REMOVING ANY STERILE PACKAGING COMPONENTS OR PROTECTIVE BALLOON COVERS. THE DEVICES MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. BOTH SABERX .014 PTA BALLOON CATHETERS WERE ABLE TO CROSS THE LESION PRIOR TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093789 ↗
• MalfunctionDec 23, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING INFLATION OF A 1.25MM X 15MM SABERX.014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, CALCIFICATION WAS ENCOUNTERED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) LESION AND THE BALLOON RUPTURED. THE DEICE WAS REMOVED AND A 1.5MM X 40M NON-CORDIS BALLOON CATHETER WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WITH NO DIFFICULTY ENCOUNTERED IN REMOVING STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. NEGATIVE PRESSURE WAS MAINTAINED DURING PREPARATION. THE TARGET VESSEL EXHIBITED NO TORTUOSITY AND 100% STENOSIS. THE DEVICE WAS NOT PLACED IN AN ACUTE BEND DURING THE PROCEDURE AND WAS UNABLE TO CROSS THE LESION. THE DEVICE DID NOT KINK. IT WAS REMOVED EASILY AND INTACT IN ONE PIECE FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881345 ↗
• MalfunctionDec 11, 2025Burst Container or Vessel; Burst Container or Vessel

  DEVICE WAS DISCARDED AT SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23785606 ↗
• InjuryAug 22, 2025Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  AS REPORTED, THE BALLOON OF A 1.25MM X 15MM SABERX .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED 6 ATMOSPHERES (ATM) DURING ITS FIRST INFLATION. WHEN ATTEMPTING TO REMOVE THE DEVICE FROM THE VESSEL, THE DEVICE WAS STUCK AND THE BALLOON PORTION STRETCHED MAKING REMOVAL IMPOSSIBLE. THE LUER HUB OF THE SABERX PTA BALLOON CATHETER WAS REMOVED AND A 5F NON-CORDIS CATHETER WAS PLACED OVER THE SABERX PTA BALLOON CATHETER, AND BOTH DEVICES WERE SUCCESSFULLY REMOVED TOGETHER. AFTER REMOVAL OF THE SABERX .014 BALLOON CATHETER, A NON-CORDIS BALLOON CATHETER WAS USED TO PERFORM PLAIN OLD BALLOON ANGIOPLASTY (POBA), AND THE PROCEDURE WAS COMPLETED. THE SABERX BALLOON CATHETER WAS BEING USED FOR PRE-DILATION OF AN ANTERIOR TIBIAL ARTERY (ATA) OCCLUSION WITH SEVERE CALCIFICATION, NO TORTUOSITY AND 100% STENOSIS. THE LESION WAS ACCESS VIA AN IPSILATERAL ANTEGRADE PUNCTURE. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE BALLOON MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO WAS 50%. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22871904 ↗
• MalfunctionAug 4, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 1.25MM X 15MM SABER .014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER MATERIAL RUPTURED DURING INFLATION AT THE LESION. THE BALLOON WAS INFLATED TO ABOUT 8 ATM WHEN IT RUPTURED. A 2.5X200 .014 SABERX BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO WAS 1:1. THE TARGET VESSEL WAS THE ANTERIOR TIBIAL ARTERY (ATA). THE TARGET SITE VESSEL WAS SEVERELY CALCIFIED, NOT TORTUOUS, AND HAD 100% STENOSIS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22703785 ↗
• MalfunctionMay 15, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 150CM SABERX014 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AND WAS REMOVED. A NON-CORDIS DEVICE WAS USED AS REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS INFLATED TO 6 ATMOSPHERES (ATM) BEFORE THE ANOMALY WAS NOTED, AND THE GAUGE OF THE INDEFLATOR INDICATED A LOSS OF PRESSURE ABOUT 3 SECONDS AFTER PRESSURE WAS MAINTAINED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY AND FEMORAL POPLITEAL WHICH HAD SEVERE CALCIFICATION AND OCCLUSION. A CONTRALATERAL APPROACH WAS MADE. AFTER AN UNKNOWN GUIDEWIRE CROSSED, AN INTRAVASCULAR ULTRASOUND (IVUS) COULD NOT CROSS AND THE COMPLAINT DEVICE WAS USED; IT CROSSED AND INFLATED; HOWEVER, RUPTURED. THE INTENDED PROCEDURE WAS AN ENDOVASCULAR THROMBECTOMY (EVT). THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DEVICE DAMAGE WAS NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING OR THE PROTECTIVE BALLOON COVER, AND NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. A CONTRALATERAL APPROACH WAS USED. THE TARGET SITE VESSEL CHARACTERISTICS INCLUDED S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031904 ↗