SABER 48002502SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032068373), received between Jun 16, 2020 and Jun 16, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionJun 16, 2020Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF 2.5MM X 2CM X 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) ¿LOSES LIQUID OVER THE SHAFT WHEN IT UNFOLDS.¿ IT CANNOT BE FULLY DEPLOYED AND THEREFORE CANNOT BE USED ON THE PATIENT. THE PHYSICIAN USED ANOTHER SABER BALLOON CATHETER WITH NO DIFFICULTIES. PATIENT¿S OUTCOME IS STABLE AND GOOD. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE RIGHT LOWER LEG. THE DEVICE WAS OPENED IN STERILE FIELD. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER AND NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. CONTRAST WAS NOT USED FOR TESTING. A NON CORDIS INFLATION DEVICE WAS USED AND IT WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE LEAKAGE WAS NOTED TO BE COMI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10157756 ↗

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