SABER 48002506XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032069264), received between May 3, 2021 and Nov 6, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2023Partial Blockage; Partial Blockage

  AS REPORTED, A 2.5MM X 6CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WOULD NOT FLUSH, AND THE GUIDEWIRE WOULD NOT PASS THROUGH THE BALLOON WIRE PORT. THE BALLOON WAS PARTIALLY LOADED. THE ISSUE OCCURRED DURING PREP. A NON-CORDIS BALLOON WAS USED AS REPLACEMENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS BEING USED FOR PERIPHERAL VASCULAR INTERVENTION. THE DEVICE WAS STORED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER NOR DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE DID NOT KINK AT ANY TIME DURING USE. THE WIRE WAS WIPED WITH A WET TELFA/GAUZE AFTER THE WIRE WAS REMOVED AND BEFORE THE WIRE WAS LOADED ON. IT IS NOT KNOWN IF THE OBSTRUCTION WAS DUE TO MATERIAL THAT COULD POSSIBLY BE INJECTED INTO THE PATIENT. THE DEVICE WAS RETURNED FOR EVALUATION. THE PRODUCT EVALUATION IDENTIFIED POLYETHYLENE PARTICLES AS THE CAUSE OF THE OBSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075328 ↗
• MalfunctionSep 8, 2022Leak/Splash; Leak/Splash

  AS REPORTED, DURING AN INFLATION TO 10 ATMOSPHERES (ATM) OF A 2.5MM X 6CM 150M SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THERE WAS A LEAKAGE COMING FROM THE BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (CTO) AND THERE WAS NO CALCIFICATION OR VESSEL TORTUOSITY PRESENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. A 50/50 CONTRAST AND SALINE MIXTURE WAS USED TO PREP THE BALLOON. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THERE WAS NO RESISTANCE EXPERIENCED DURING INSERTION OF THE DEVICE. THE DEVICE WAS ABLE TO TRACK TOWARD THE LESION AND CROSS THE LESION WITHOUT DIFFICULTY. THE DEVICE WAS NEVER PLACED IN AN ACUTE BEND, AND IT DID NOT KINK DURING ITS USE. THE DEVICE WAS ABLE TO BE REMOVED EASILY AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382461 ↗
• MalfunctionMay 3, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 2.5MM X 6CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED ¿WITHOUT HITTING THE BLASTING PRESSURE¿. IT WAS THEN WITHDRAWN. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11759220 ↗

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