SABER 48003515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032069387), received between May 21, 2022 and Nov 19, 2025 — classified as 2 malfunctions.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON ON A 3.5MM X 15CM SABER .018 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 8 ATMOSPHERES (ATM). A 3MM X 30CM SABER .018 PTA BALLOON CATHETER WAS THEN USED FOR SUCCESSFUL DILATION, FOLLOWED BY THE USE OF A NON-CORDIS DRUG-COATED BALLOON (DCB). THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO PERFORM RECANALIZATION OF A LOWER LIMB ARTERIAL OCCLUSION. THE TARGET VESSEL WAS THE FEMORAL-POPLITEAL ARTERY AT THE P1 SEGMENT. THE TARGET VESSEL EXHIBITED SEVERE CALCIFICATION, NO TORTUOSITY, AND 80% STENOSIS. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STERILE PACKAGING COMPONENTS OR THE PROTECTIVE BALLOON COVER. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS NOT PLACED INTO AN ACUTE BEND AND WAS ABLE TO CROSS THE LESION WITHOUT KINKING. THE DEVICE WAS REMOVED EASILY FROM THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597046 ↗
• MalfunctionMay 21, 2022Partial Blockage; Partial Blockage

  AS REPORTED, THE SABER 3.5MM 15CM 150 HAD SOMETHING STUCK INSIDE THE BALLOON; THEREFORE, THE NON-CORDIS WIRE COULD NOT PASS THROUGH THE DEVICE. THE CASE WAS COMPLETED WITH A NEW CORDIS BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS NEVER INSERTED INTO THE PATIENT. THE DEVICE WAS ATTEMPTED TO BE PREPPED PER THE IFU. THE OBSTRUCTION WAS NOTICED WHILE PRE-LOADING OUTSIDE THE PATIENT ONTO THE NON-CORDIS GUIDEWIRE. THE CATHETER WAS NEVER IN AN ACUTE BEND AND THE CATHETER WAS NEVER KINKED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465017 ↗

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