SABERX .014 PTA Dilatation Catheter 47530300LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032088722), received between Feb 11, 2025 and Feb 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, THE PHYSICIAN WAS TREATING THE ANTERIOR TIBIAL (AT) WITH THE 3.0 X 300 .014 SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WHEN THE BALLOON RUPTURED WHEN IT WAS INITIALLY INFLATED TO APPROXIMATELY 14 ATM. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOT INTACT. THE PHYSICIAN HAD TO GO BACK IN WITH A SNARE AND REMOVE THE REMAINING BALLOON MATERIAL. ALL MATERIAL WAS REMOVED FROM THE PATIENT. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE PROCEDURE AS PLANNED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTIES IN REMOVING IT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET, OR ANY STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED ACCORDING TO THE IFU AND MAINTAINED NEGATIVE PRESSURE DURING PREP. THE INTENDED PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF A LESION IN THE ANTERIOR TIBIAL ARTERY. THE DEVICE WAS BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) WITH MODERATE CALCIUM. THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO RESISTANCE OR FRICTION WHILE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459538 ↗
• MalfunctionFeb 11, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3.0 X 300 .014 SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURE DURING TREATMENT. THE BALLOON RUPTURED UPON INITIAL INFLATION AT APPROXIMATELY 14 TO 15 ATM. THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED AS PLANNED USING A NEW SABER .014 BALLOON OF THE SAME SIZE. THERE WAS NO ADVERSE EVENT WAS REPORTED. THE PHYSICIAN WAS TREATING A CHRONIC TOTAL OCCLUSION (CTO) IN THE POSTERIOR TIBIAL (PT) ARTERY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357408 ↗