SABER 48007006XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032069684), received between Apr 22, 2022 and Apr 22, 2022 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A SABER 7MM 6CM 150 BURST BELOW NOMINAL PRESSURE WHILE IN THE VESSEL. IT WAS ALSO NOTED THAT THE BALLOON RUPTURED WHILE IN A STENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE INTENDED PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS NOTED TO BE CALCIFIED. THE VESSEL DID NOT HAVE ANY TORTUOSITY. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE DEVICE THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE CATHETER ADVANCED THROUGH THE VESSEL WITHOUT DIFFICULTY. THE DEVICE CROSSED THE LESION WITHOUT DIFFICULTY. THE CATHETER WAS NEVER IN AN ACUTE BEND AND WAS NEVER KINKED. THE DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190884 ↗

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