SABER 48002006XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032069912), received between Jun 13, 2024 and Jan 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 2MM 6CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOONS THAT IS FAULTY. THE DEVICE WAS OPENED, AND THE TIP HAD COME OFF SO IT WAS NOT USED INSIDE THE PATIENT / DURING THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067167 ↗
• MalfunctionJun 13, 2024Deflation Problem; Deflation Problem

  AS REPORTED, THE OPERATOR CHOSE A BALLOON 2*60MM SABER BALLOON FOR DILATATION. AFTER DILATATION, THE BALLOON WAS NOT EASILY DEFLATED TO THE ORIGINAL STATE. THE OPERATOR DID THE SECOND INFLATION, AND THE BALLOON COULD NOT BE INFLATED COMPLETELY. THE PRODUCT WAS THEN WITHDRAWN, AND THE PROCEDURE WAS COMPLETED USING OTHER DEVICES. THERE WAS NO REPORTED INJURY TO THE PATIENT. A RETROGRADE PUNCTURE WAS MADE TO THE RIGHT FEMORAL ARTERY. AN ANTERIOR FEMORAL ARTERY OCCLUSION WAS SEEN ON IMAGING. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. ADDENDUM: PRODUCT EVALUATION REVEALED A DETACHED PIECE OF THE INNER BODY OBSTRUCTING THE GUIDEWIRE LUMEN OF THE SABER BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533183 ↗

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