SABER 48004020SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032069806), received between Apr 7, 2017 and Apr 7, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 7, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE SABER BALLOON CATHETER TIP CAME OFF DURING PREPARATION. A NEW SAVER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO DAMAGES NOTED TO THE DEVICE PACKAGING. THERE WAS NO FORCE USED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6471849 ↗

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