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SABER 48006025XRecalls & reported problems

Cordis Corporation · SABER 6MM25CM 150 · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032069646), received between Jan 3, 2023 and Jan 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Partial Blockage” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Partial Blockage1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 3, 2023Partial Blockage; Partial Blockage

    AS REPORTED, DURING PREPARATION OF A 6MM X 25CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, IT WAS NOT POSSIBLE TO FLUSH THE DEVICE AND IT WAS REPORTED THAT THE DEVICE APPEARED KINKED. AS A RESULT, THE DEVICE WAS NOT USED IN THE PATIENT, AND A 6MM X 25CM .018 SABER PTA BALLOON CATHETER WAS USED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT WAS REPORTED THAT THE DAMAGE WAS OBSERVED AFTER THE DEVICE WAS REMOVED FROM ITS STERILE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM ITS PACKAGING AND THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED AN ADHESIVE PLUG OBSTRUCTING THE GUIDEWIRE LUMEN OF THE SABER PTA BALLOON CATHETER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16091137 ↗

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

Other Catheter, angioplasty, peripheral, transluminal devices

All Catheter, angioplasty, peripheral, transluminal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.