Saber .035 48006006RRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 6mm x 60mm 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032080863), received between Mar 10, 2025 and Mar 10, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
- Detachment of Device or Device 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.
InjuryMar 10, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
AS REPORTED, A 6 MM X 60 MM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS OPENED AND USED FOR PTA IN THE RIGHT EXTERNAL ARTERY AT 10 ATMOSPHERES (ATM) FOR 30 SECONDS. A NON-CORDIS STENT WAS PLACED AND THE SAME 6 MM X 60 MM SABER .035 PTA BALLOON CATHETER WAS USED TO POST DILATE THE STENT IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AT 12 ATM FOR 15 SECONDS WHEN A BALLOON RUPTURE OCCURRED. WHEN THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT, THE BALLOON WAS NOT INTACT. HALF OF THE BALLOON AND THE ENTIRE DELIVERY SHAFT THAT RUNS THROUGH THE BALLOON PORTION WAS LEFT IN THE PATIENT. THE SEPARATED BALLOON WAS SNARED, AND ONE RADIOPAQUE BALLOON MARKER WAS ABLE TO BE SNARED INTO AN UNKNOWN SHEATH. HOWEVER, THE OTHER RADIOPAQUE BALLOON MARKER WAS LEFT IN THE RIGHT COMMON FEMORAL ARTERY AND WAS UNABLE TO BE RETRIEVED. NO ADDITIONAL INTERVENTION WAS PERFORMED AFTER ATTEMPTS TO SNARE THE SEPARATED SEGMENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE CONTRAST TO SALINE RATIO WAS 60% SALINE AND 40% CONTRAST. THE TARGET VESSEL WAS SEVERELY CALCIFIED, NOT TORTUO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21559482 ↗
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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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