Saber .035 48012004NRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 12mm x 40mm 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 20705032080504), received between Sep 22, 2022 and Sep 22, 2022 — 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.
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 22, 2022Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF THE SABER. 035 10MM 4CM BURST AT RATED BURST PRESSURE ON THE FIRST INFLATION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS DISCARDED. ADDITIONAL INFO WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15467776 ↗
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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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