Saber .035 48005010RRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 5mm x 100mm 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 20705032080528), received between Jan 9, 2026 and Jan 9, 2026 — 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 16, 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.
MalfunctionJan 9, 2026Burst Container or Vessel
AS REPORTED, DURING AN ATTEMPT TO INFLATE THE BALLOON ON A 5MM X 100MM SABER .035 PERCUTANEOUS TRANSLATION ANGIOPLASTY (PTA) BALLOON CATHETER USING A PRESSURE PUMP WAS UNSUCCESSFULLY. AFTER REMOVING THE DEVICE, IT WAS FOUND TO HAVE RUPTURED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A MINIMALLY INVASIVE DIRECT ANGIOPLASTY. ADDITIONAL DETAILS ARE NOT AVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24020774 ↗
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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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