SABER 48003506XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032069356), received between Mar 1, 2019 and Mar 1, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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

Recent adverse event reports

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

• MalfunctionMar 1, 2019Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, A SABER BALLOON CATHETER (3.5MM6CM 150) WAS FOUND TO HAVE A HOLE IN THE MIDDLE THIRD OF THE SHAFT DISTAL FROM THE CATHETER THAT WOULD NOT ALLOW THE BALLOON TO BE INFLATED. ANOTHER BALLOON WAS OPENED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8382685 ↗

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