SABER 48008010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032068878), received between Nov 23, 2025 and Nov 23, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 23, 2025Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, A SABER 8MMX10CM 90 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BROKE OFF IN THE ARM AND THE DOCTOR HAD TO OPEN THE ARM TO REMOVE THE DEVICE. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION AND WAS NOT SUBJECTED TO AN ACUTE BEND DURING THE PROCEDURE. IT CROSSED THE LESION EASILY WITHOUT KINKING OR ANOMALIES DURING DELIVERY. HOWEVER, DURING A SECOND INFLATION AT 10¿12 ATMOSPHERES (ATM) WITHIN A STENTED SEGMENT, THE BALLOON RUPTURED AND COULD NOT BE RETRACTED EASILY. THE DEVICE COMPLETELY SEPARATED. A SECOND SHEATH WAS INSERTED AND THE WIRE WAS SNARED TO PREVENT MIGRATION. A SURGICAL CUTDOWN WAS PERFORMED AT THE INITIAL SHEATH ENTRY SITE, THE INITIAL SHEATH WAS REMOVED AND THE SEPARATED COMPONENTS WERE RETRIEVED FROM THE LUMEN, INCLUDING THE WIRE. THE DEVICE WAS NOT REMOVED INTACT. THE BALLOON AND MARKERS SEPARATED FROM THE INNER HYPOTUBE, WHICH ALSO DETACHED FROM THE CATHETER SHAFT. A SURGICAL CUTDOWN WAS CONFIRMED AS NECESSARY FOR REMOVAL. THE BALLOON WAS NOT CAUGHT IN THE LESION BUT WAS PROBABLY CAUGHT IN A PREVIOUSLY DEPLOYED NON-CORDIS STENT GRAFT PLACED ON (B)(6) 2012. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER OR ANY

  Patient problems: Foreign Body In Patient

  MAUDE report 23627670 ↗

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