Saber .035 48005008NRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 5mm x 80mm x 80cm · 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 20705032080658), received between Dec 20, 2022 and Dec 20, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Most reported problems
Device problems
- Difficult to Remove1
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.
MalfunctionDec 20, 2022Difficult to Remove; Difficult to Remove
AS REPORTED, AFTER THE INITIAL INFLATION OF A 5MM X 8CM 80CM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, THE BALLOON WAS DIFFICULT TO WITHDRAW THROUGH A 5F 11CM BRITE TIP CATHETER SHEATH INTRODUCER (CSI). IT WAS REPORTED THAT THE SECONDARY PROFILE OF THE SABER .035 PTA BALLOON WAS LARGER THAN THE INNER DIAMETER OF THE 5F CSI. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE ACCESS VESSEL HAD MILD CALCIFICATION AND MILD TORTUOSITY. THERE WAS NO DAMAGE TO THE BRITE TIP CSI. THE CSI WAS ABLE TO BE USED SUCCESSFULLY WITH OTHER DEVICES DURING THIS PROCEDURE AND WAS USED THROUGHOUT THE DURATION OF THE PROCEDURE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS, AND THE DEVICE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO BEING INSERTED INTO THE PATIENT. THERE WAS NO RESISTANCE OR FRICTION EXPERIENCED DURING INSERTION OF THE DEVICE. THE DEVICE WAS ABLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16018091 ↗
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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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