Saber .035 48006002NRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 6mm x 20mm 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 20705032079799), received between Nov 19, 2025 and Nov 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
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.
MalfunctionNov 19, 2025Deflation Problem; Deflation Problem
AS REPORTED, THE BALLOON OF A 6MM X 20MM SABER .035 80CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER COULD NOT BE DEFLATED AFTER SUCCESSFUL DILATION. DESPITE MULTIPLE ATTEMPTS USING A NON-CORDIS INFLATION/DEFLATION DEVICE, DEFLATION COULD NOT BE ACHIEVED. AFTER MULTIPLE ATTEMPTS AND REPEATED MANEUVERS USING BOTH THE UNKNOWN SHEATH AND THE INFLATION/DEFLATION DEVICE WAS THE BALLOON FINALLY ABLE TO DEFLATE. NO HARM OCCURRED TO THE PATIENT AND THERE WERE NO REPORTED PATIENT INJURIES. THIS WAS DURING AN INTERVENTIONAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597881 ↗
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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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