Saber .035 48007004RRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 7mm x 40mm 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 20705032080122), received between Sep 15, 2025 and Sep 15, 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.
MalfunctionSep 15, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, A 7X40 .035 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON RUPTURED AT NOMINAL PRESSURE AFTER BEING INFLATED INSIDE OF A STENT. THE BALLOON RUPTURED BELOW THE RATED BURST PRESSURE (RBP). THE PROCEDURE WAS COMPLETED WITH POST-DILATATION USING A SABER .035 PTA BALLOON. NO HARM OR INJURY OCCURRED TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU). THE BALLOON WAS REMOVED FROM THE HOOP, PROTECTIVE COVER, AND STERILE PACKAGING WITHOUT DIFFICULTY. THERE WERE NO KINKS OR DAMAGES WERE NOTED PRIOR TO INSERTION. THE DEVICE WAS PREPPED ACCORDING TO THE IFU AND MAINTAINED NEGATIVE PRESSURE NORMALLY. THE INTENDED PROCEDURE TARGETED A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA), WHICH WAS SEVERELY CALCIFIED WITH NO VESSEL TORTUOSITY AND 70¿80% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). NO RESISTANCE OR FRICTION OCCURRED DURING INSERTION THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE ADVANCING THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NOT IN AN ACUTE BEND AND DID NOT KINK DURING USE. A 50/50 CONTRAST-TO-SALINE RATIO WAS USED. THE AFFECTED UNIT WAS DISCARDED BY THE STAFF POST PROCEDURE AND IS N
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23054843 ↗
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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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