SABERX .014 PTA Dilatation Catheter 47525150MRecalls & reported problems
Cordis US Corp. · PTA, RX, 2.5 x 150, 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 20705032089927), received between Jul 30, 2025 and Jul 30, 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.
MalfunctionJul 30, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE 2.5 X 150 .014 SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS USED AND DILATED AT 16 ATM. HOWEVER, IT RUPTURED ON THE FIRST INFLATION. THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND WHILE CROSSING THE LESION. A NON-CORDIS 2.5 MM X 150MM BALLOON WAS USED INSTEAD AND EXPANDED WITHOUT ISSUES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS OCCURRED IN A BELOW THE KNEE CASE VIA IPSILATERAL APPROACH. A NON-CORDIS .014 WIRE CROSSED THE LESION. 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. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. THE INTENDED PROCEDURE WAS EVT. THE LESION HAD LITTLE CALCIFICATION. THE VESSEL TORTUOSITY WAS MODERATE. THE PERCENTAGE OF STENOSIS WAS 70%. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE OR FRI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22667058 ↗
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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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