SABERX .014 PTA Dilatation Catheter 47530300MRecalls & reported problems
Cordis US Corp. · PTA, RX, 3.0 x 300, 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
- 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 20705032088753), received between Apr 28, 2025 and Mar 18, 2026 — classified as 2 malfunctions.
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
- Decrease in Pressure1
- Material Rupture1
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.
MalfunctionMar 18, 2026Burst Container or Vessel
AS REPORTED, THE 3.0 X 300 SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON PASSED THROUGH THE NON-CORDIS FIXED CATHETER (FC). HOWEVER, THE BALLOON RUPTURED BEFORE REACHING NOMINAL PRESSURE/SIZE. AFTERWARDS, A 3.0 X 200 SABERX BALLOON WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24632396 ↗MalfunctionApr 28, 2025Decrease in Pressure; Material Rupture; Decrease in Pressure; Material Rupture
AS REPORTED, A 3.0 X 300, 150CM, .014 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 4 ATMOSPHERES. THE DEVICE WAS REPLACED WITH A NEW DEVICE, WHICH INFLATED AT ITS NOMINAL PRESSURE. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY, WHERE A CONTRALATERAL APPROACH WAS MADE AND A 6F NON-CORDIS SHEATH WAS USED. A NON- CORDIS GUIDEWIRE CROSSED AND AFTER THAT THE SABER WAS USED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21923403 ↗
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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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