SABER 48003525XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032069400), received between Feb 17, 2020 and May 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 15, 2023Deflation Problem; Deflation Problem

  AS REPORTED, AFTER INFLATION OF A 3.5MM X 25CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON COULD NOT BE EASILY DEFLATED. AN ATTEMPT TO RE-DILATE THE BALLOON WAS MADE, HOWEVER; THE BALLOON COULD NOT BE FULLY INFLATED. DESPITE THE DIFFICULTY DEFLATING THE BALLOON, THE BALLOON WAS ABLE TO BE FULLY DEFLATED AFTER REPEATEDLY INFLATING AND DEFLATING THE BALLOON, AND THE DEVICE WAS THEN WITHDRAWN ALONG AN UNKNOWN GUIDEWIRE. A 3.5MM X 20CM NON-CORDIS BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 75% OCCLUSION OF THE P3 SEGMENT WITHIN THE POPLITEAL ARTERY WHICH WAS VISUALIZED DURING ANGIOGRAPHY. THE LESION SHOWED NO SIGNS OF CALCIFICATION OR TORTUOSITY. AN ANTEGRADE APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY FOR THIS PROCEDURE. THE DEVICE WAS STORED AND PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE BALLOON WAS PREPPED WITH A 1:1 CONTRAST TO SALINE RATIO. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE BALLOON WAS INITIALLY INFLATED TO 15 ATMOSPHERES (ATM). T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16930494 ↗
• MalfunctionFeb 17, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3.5MM X 25CM X 150 SABER BALLOON CATHETER BURST WHEN INFLATION WAS ATTEMPTED WHILE IN PATIENT. THE BALLOON INFLATED NORMALLY UNTIL IT WAS RUPTURED BY CALCIUM. THE MAXIMUM INFLATION PRESSURE WAS 12 ATMOSPHERES. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. ANOTHER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS NOT INJURED. THE INTENDED PROCEDURE WAS ANGIOPLASTY FOR PERIPHERAL VASCULAR DISEASE BELOW THE KNEE. 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. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY. THEY USED A NON-CORDIS SHEATH AND NON-CORDIS GUIDE WIRE. THEY USED A NON-CORDIS INFLATION DEVICE. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THEY USED A NON-CORDIS CONTRAST MEDIA. THE CONTRAST SALINE RATIO WAS 50/50. THERE WERE NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9717572 ↗

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