Saber .035 48006030RRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 6mm x 300mm x 135cm · 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 20705032080245), received between Apr 4, 2022 and Apr 4, 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 18, 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.
MalfunctionApr 4, 2022Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A SABER .035 6MM 30CM 135 RUPTURED AT 8 ATM WHILE IN A IN-STENT RESTENOSIS. THE PROCEDURE WAS COMPLETED AFTER THE USE OF A NEW SABER 035 6MM X 200MM BALLOON CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. IT WAS NOTED THAT THIS BALLOON IS PART OF A PRE-MARKET TRIAL. THE PRODUCT WAS STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING THE STYLET/STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS PREPPED NORMALLY. THE DEVICE WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A CONTRALATERAL APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY. THE LESION WAS NOTED TO HAVE MODERATE-SEVERE CALCIFICATION. THE VESSEL DID NOT HAVE ANY TORTUOSITY. THE LESION HAD AN 80% STENOSIS. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THE BALLOON THOUGH THE UNKNOWN GUIDE CATHETER. THE CATHETER ADVANCED THROUGH THE VESSEL AND LESION WITHOUT DIFFICU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13999926 ↗
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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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