Saber .035 48006012RRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 6mm x 120mm 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 20705032080849), received between May 26, 2023 and May 26, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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.
Most reported problems
Device problems
- Leak/Splash1
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.
MalfunctionMay 26, 2023Leak/Splash; Leak/Splash
AS REPORTED, BLOOD WAS NOTED IN THE INDEFLATOR AFTER INFLATION OF THE BALLOON OF A SABER .035 6MM X 12CM 135 CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE RIGHT ILIAC ARTERY AT 4 ATMOSPHERES (ATM). THE PHYSICIAN REMOVED THE BALLOON FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH THE USE OF NON-CORDIS BALLOONS AND ANOTHER .035 SABER WITHOUT ISSUE. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE BEING PERFORMED WAS REPORTED TO BE A RIGHT LEG ANGIOGRAM AND A RETROGRADE APPROACH WAS USED, USING A NON-CORDIS SHEATH. VESSEL CALCIFICATION WAS MODERATE TO SEVERE IN PLACES; VESSEL TORTUOSITY WAS ALSO SEVERE WITH ONE-HUNDRED PERCENT STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED, HANDLED , AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER NOR DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE MAINTAINED NEGATIVE PRESSURE DU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17009816 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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