Saber .035 48008010NRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 8mm x 100mm x 80cm · 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 20705032080375), received between Aug 5, 2023 and Aug 5, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
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.
MalfunctionAug 5, 2023Defective Component; Defective Component
AS REPORTED, THE BALLOON MARKERS OF A SABER 0.35 8X100 MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DILATATION CATHETER WERE NOT CLEAR UNDER FLUOROSCOPY; THEY HAD TROUBLE WITH THE VISIBILITY ON SCREENING. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FORM THE PATIENT. ALL THE MARKER BANDS (PROXIMAL AND DISTAL) WERE PRESENT ON THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, NOT PROVIDED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17467142 ↗
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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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