Saber .035 48010008RRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 10mm x 80mm x 135cm · Class 2
All models of Saber .035 (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032081051), received between Mar 31, 2025 and Mar 31, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 10MM X 80MM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT BE INFLATED AND THERE WAS CONTRAST EXPOSED. AFTER REMOVING THE DEVICE FROM THE PATIENT, THE BALLOON WAS FILLED AND A RUPTURE HOLE IN THE BALLOON WAS FOUND. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A DILATATION OF THE COMMON ILIAC ARTERY IN A PROCEDURE TO TREAT A LOWER EXTREMITY ARTERIAL OCCLUSION. THE TARGET SITE VESSEL CHARACTERISTICS WERE SEVERE CALCIFICATION, NO TORTUOSITY, AND 80% STENOSIS. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE CONTRAST TO SALINE RATIO WAS 1:1. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21732141 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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