SABERX .014 PTA Dilatation Catheter 47540150MRecalls & reported problems
Cordis US Corp. · PTA, RX, 4.0 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 20705032087169), received between Jan 9, 2026 and Jan 9, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
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.
MalfunctionJan 9, 2026Material Rupture
AS REPORTED, A 4 MM X 15 CM SABERX .014 150 CM PTA BALLOON CATHETER RUPTURED DURING INFLATION AFTER EXCEEDING NOMINAL PRESSURE. AFTER THE BALLOON RUPTURE, DILATION WAS PERFORMED WITH A NEW UNKNOWN 4 MM X 4 CM BALLOON, FOLLOWED BY AN UNKNOWN DRUG-COATED BALLOON, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE INVOLVED TREATMENT OF LEFT SUPERFICIAL FEMORAL ARTERY (SFA) TO BELOW-KNEE ARTERY (BKA) STENOSIS VIA RIGHT GROIN ACCESS, INSERTION OF AN UNKNOWN 6F GUIDING SHEATH, LESION CROSSING WITH AN UNKNOWN 0.014 GUIDEWIRE, AND PRE-DILATION USING AN UNKNOWN 1.25 MM X 1.5 CM BALLOON FOLLOWED BY AN UNKNOWN 3 MM X 4 CM BALLOON. IT WAS UNCLEAR WHETHER THE CAUSE OF THE BALLOON RUPTURE WAS LESION CALCIFICATION OR PRODUCT QUALITY. THE PRODUCT WAS STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DIFFICULTIES REMOVING IT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET, OR ANY STERILE PACKAGING COMPONENTS. NO KINKS OR DAMAGES WERE NOTED PRIOR TO INSERTION. THE DEVICE WAS PREPPED ACCORDING TO THE IFU AND MAINTAINED NEGATIVE PRESSURE NORMALLY. THE INTENDED PROCEDURE WAS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) USING A CONTRALATERAL AP
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24026126 ↗
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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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