Saber .035 48012004RRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 12mm x 40mm x 135cm · Class 2
All models of Saber .035 (21)
Data updated Oct 16, 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 20705032080634), received between Jul 17, 2024 and Jul 17, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Frayed1
- Material Split, Cut or Torn1
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.
MalfunctionJul 17, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn
AS REPORTED, THE BALLOON OF A 12MM X 40MM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DID NOT FILL WHEN INSIDE OF THE PATIENT. THE OPERATOR WITHDREW THE DEVICE AND ATTEMPTED TO INFLATE THE BALLOON OUTSIDE OF THE PATIENT WHERE A SMALL HOLE IN THE BODY OF THE BALLOON WAS OBSERVED BUBBLING FLUID. THE PROCEDURE WAS ENDED AND THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO DILATE A DIALYSIS ACCESS STENOSIS IN A SUPERIOR VENA CAVA (SVC) WHICH HAD A 70% SEPTAL STENOSIS. AN APPROACH FROM THE RIGHT INTERNAL JUGULAR VEIN WAS MADE FOR THIS PROCEDURE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED WITH A 50/50 CONTRAST AND SALINE MIXTURE AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE OPERATOR IS TRAINED AND EXPERIENCED IN THE USE OF BALLOON CATHETERS. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19765566 ↗
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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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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