Saber .035 48005020RRecalls & reported problems
Cordis Corporation · SABER .035 PTA Dilation Catheter 5mm x 200mm 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 20705032080412), received between Dec 17, 2021 and Dec 17, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- 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.
MalfunctionDec 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THE BALLOON PROTECTION COVER COULD NOT BE REMOVED DURING THE PREP OF A SABER (035) 5MM 20CM 135CM. AFTER SEVERAL ATTEMPTS TO REMOVE, THE BALLOON COULD NOT BE USED FOR THE PROCEDURE. ALSO NOTED, A SEPARATION OF THE BODY/SHAFT OCCURRED DUE TO THE BALLOON COVER REMOVAL DIFFICULTY. THE BALLOON WAS NEVER IN CONTACT WITH THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, STYLET AND/OR REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. BESIDES THE BALLOON COVER DIFFICULTY, NO DIFFICULTY WAS NOTED DURING PREP. THERE WAS NO DAMAGE TO THE ACTUAL BALLOON. THE DEVICE WILL BE SENT BACK FOR EVALUATION. SEPARATION FOUND DURING PRODUCT EVALUATION AND VERIFIED THROUGH ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13026822 ↗
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