SABER 48002008XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032069929), received between Nov 10, 2020 and Nov 10, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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.

• MalfunctionNov 10, 2020Material Rupture; Material Rupture

  A 5MM X 10CM X 155CM SABER RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT APPROXIMATELY NOMINAL PRESSURE DURING USE. THEREFORE, IT WAS REPLACED WITH A 6MM X 10CM X 155CM SABER RX PTA BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY WHICH HAD A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10817161 ↗

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