Saber .035 48005004RRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 5mm x 40mm 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 20705032079744), received between Feb 3, 2025 and Feb 3, 2025 — 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.
Reports received per month
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.
MalfunctionFeb 3, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 5MM X 40MM 135CM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING A PERIPHERAL PROCEDURE. ADDITIONALLY, A 6MM X 6CM SABER .018 PTA BALLOON CATHETER WAS USED, BUT THE BALLOON RUPTURED IN TWO PIECES. THE DEVICES WERE ABLE TO BE REMOVED EASILY FROM THE PATIENT. AN UNKNOWN SNARING DEVICE WAS USED TO RETRIEVE THE SEPARATED BALLOON, BUT IT WAS NOT SUCCESSFUL. OTHER UNKNOWN BALLOONS WERE USED DURING THIS PROCEDURE. THIS WAS DURING A PROCEDURE TO TREAT A LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) LESION WHICH WAS TORTUOUS. THE DEVICES WERE "RESTORED" PROPERLY PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO ISSUES REMOVING THE STERILE PACKAGING. THE DEVICES MAINTAINED NEGATIVE PRESSURE DURING PREPARATION AND WERE PREPPED WITH A 60% CONTRAST AND 40% SALINE MIXTURE. BOTH DEVICES WERE INFLATED TO 8 ATMOSPHERES (ATM). THE DEVICES WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21291813 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page