SABER 48003010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032068076), received between Feb 24, 2020 and Dec 26, 2022 — 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.

• MalfunctionDec 26, 2022Difficult to Remove; Device Contamination with Chemical or Other Material; Difficult to Remove; Device Contamination with Chemical or Other Material

  AS REPORTED, THE PHYSICIAN TRIED TO REMOVE SABER .018 3MM10CM BALLOON OVER THE .014 GLIDEWIRE BUT GOT STUCK. SO, IT WAS PULLED FIRMLY AND THEN IT FINALLY CAME OUT. THE PHYSICIAN TRIED TO ASPIRATE THROUGH BALLOON BUT COULDN¿T. IT SEEMED TO BE THAT SOMETHING WAS JAMMED AT TIP. AT THIS POINT, EVERYTHING WAS REMOVED. IT WAS NOTICED THERE WAS SMALL FRAGMENT AT THE TIP OF THE BALLOON. THE PATIENT'S VESSELS WERE NOT BADLY DISEASED. THE OPERATOR DOESN'T THINK THIS WAS A FACTOR. THE OPERATOR BELIEVES SABER .018 BALLOON IS INCOMPATIBLE WITH THAT NON-CORDIS GLIDEWIRE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED PER INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE DEVICE WAS PREPPED PER THE IFU WITH NO DIFFICULTY. THE FEMORAL ARTERY WAS USED WITH AN ANTEGRADE APPROACH. THE INTENDED PROCEDURE WAS A DISTAL BYPASS, BELOW THE KNEE, AND GRAFT PTA. THE LESION WAS NOTED TO HAVE NO CALCIFICATION OR VESSEL TORTUOSITY. THE LESION WAS PRE-BALLOONED WITH 2MM WITH AN UNKNOWN DEVICE. NORMALLY USES THE BALLOON AS A CATHETER. ANOTHER SEGMENT OF THE LESION W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048023 ↗
• MalfunctionFeb 24, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER 90 3MM X 10CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT ITS NOMINAL PRESSURE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS ALREADY DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9747171 ↗

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