SABER 48003025SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032068120), received between Nov 17, 2020 and Nov 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or 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.

• MalfunctionNov 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AT SOME POINT IN THE PROCEDURE, THE BALLOON OF 3MM X 25CM X 90CM SABER RAPID EXCHANGE (RX) BALLOON CATHETER (BC) BROKE APART FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DOCTOR WAS PERFORMING A SUBINTIMAL ANGIOPLASTY OF A PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WILL BE RETURNED FOR ANALYSIS. IMAGE IS AVAILABLE FOR REVIEW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10853147 ↗

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