SABER .014 PTA Dilatation Catheter 47030300MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032089095), received between Nov 17, 2023 and May 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A SABER .014 PTA OTW, 3.0 X 300, 150CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER SEPARATED FROM ITS SHAFT AND RAIL DURING REMOVAL FROM THE PATIENT. A NON-CORDIS SNARE WAS USED TO REMOVE THE SECTION OF BALLOON THAT REMAINED OVER THE UNKNOWN WIRE IN THE PATIENT. THE BALLOON WAS REMOVED SUCCESSFULLY, AND NO HARM WAS CAUSED TO THE PATIENT. A CONTRALATERAL APPROACH WAS USED. THE TARGET SITE VESSEL WAS CALCIFIED, NO TORTUOSITY, NO ACUTE OR BIFURCATING ANGLE. THE VESSEL CHARACTERISTICS ACCESSING TARGET SITE HAD NO CALCIFICATION, TORTUOSITY, NO ACUTE OR BIFURCATING ANGLE. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. 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, HOWEVER WAS CAUGHT IN IT. THE BALLOON COULD HAVE POTENTIALLY BEEN CAUGHT IN A DEPLOYED STENT, AS THE SECTION OF THE BALLOON THAT BECAME SEPARATED WAS FOUND DISTAL TO AN EXISTING STENT. THE DEVICE DID NOT KINK AT ANY TIME DURING THE PROCEDURE. THERE WERE NO ANOMALIES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971889 ↗
• MalfunctionNov 17, 2023Material Frayed; Leak/Splash; Material Split, Cut or Torn; Material Frayed; Leak/Splash; Material Split, Cut or Torn

  AS REPORTED, THE 3X300 SABER .014 BALLOON EXTENDS SIGNIFICANTLY PAST THE PROXIMAL MAKERS AND SEEM TO MOVE, OR ¿DANCE¿, WITH INCREASING PRESSURE APPLIED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE CASE WAS COMPLETED WITH A NEW 3X300 SABER .014 BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, 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 PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE CATHETER WAS NEVER IN AN ACUTE BEND AND WAS NEVER KINKED DURING USE. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE LESION WAS IN THE TIBIAL ARTERY. THE LESION WAS NOTED TO HAVE MINIMAL CALCIFICATION. THE VESSEL DID NOT HAVE ANY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160851 ↗