SABERX .014 PTA Dilatation Catheter 47530040MRecalls & reported problems
Cordis US Corp. · PTA, RX, 3.0 x 40, 150cm · Class 2
All models of SABERX .014 PTA Dilatation Catheter (16)
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 20705032088777), received between Apr 8, 2026 and Apr 8, 2026 — 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.
MalfunctionApr 8, 2026Burst Container or Vessel
AS REPORTED, A 3MM X 40MM SABERX .014 RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED WITHOUT ISSUE USING AN UNKNOWN REPLACEMENT PRODUCT. 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 PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE 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. THE DEVICE WAS PREPPED NORMALLY. THE DEVICE WAS USED FOR AN ENDOVASCULAR THROMBECTOMY (EVT). THERE WAS SEVERE VESSEL CALCIFICATION WITHOUT TORTUOSITY AND 100% STENOSIS. THERE WAS NO RESISTANCE OR FRICTION WILE INSERTING THE BALLOON THROUGH THE THROUGH THE ROTATING HEMOSTATIC VALVE, THE GUIDE CATHETER OR ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION WITH THE BALLOON CATHETER AND THE CATHETER WAS NEVER IN AN ACUTE BEND. THERE WAS NO BALLOON CATHETER KINK DURING USE. THE CONTRAST TO SALINE RATIO WAS 2:1. THE P
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24821749 ↗
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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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