Saber .035 48010004NRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 10mm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032080085), received between Sep 29, 2023 and Dec 9, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).
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 Vessel2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 10X40 .035 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS OPENED AND PREPPED IN STERILE FIELD AS PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT INSERTED THROUGH AN UNKNOWN SHEATH TO TARGET LESION. THE PHYSICIAN PERFORMED HAND INFLATION AND PTA BALLOON BURST. THE PRODUCT WAS DISCARDED AND ADDITIONAL PTA BALLOON USED TO FINISH CASE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20880433 ↗MalfunctionSep 29, 2023Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
AS REPORTED, THE BALLOON OF A 10MM X 40MM 80CM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY, AND PART OF THE BALLOON CATHETER BROKE OFF INSIDE OF THE PATIENT. THIS WAS DURING THIS INITIAL INFLATION OF THE DEVICE WITHIN A SEVERELY CALCIFIED LESION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17842983 ↗
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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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