SABERX .014 PTA Dilatation Catheter 47550200MRecalls & reported problems
Cordis US Corp. · PTA, RX, 5.0 x 200, 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 20705032087893), received between May 15, 2025 and May 15, 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.
MalfunctionMay 15, 2025Burst Container or Vessel; Burst Container or Vessel
AS REPORTED, THE BALLOON OF A 5MM X 200CM SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING ITS INITIAL INFLATION AND WAS REMOVED. A NON-CORDIS DEVICE WAS USED AS REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS AN ENDOVASCULAR TREATMENT (EVT) AND A CONTRALATERAL APPROACH WAS MADE. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY AND FEMORAL POPLITEAL WHICH HAD SEVERE CALCIFICATION AND OCCLUSION. AFTER AN UNKNOWN GUIDEWIRE CROSSED, THE SABER X WAS USED AS PRE-DILATION. IT CROSSED THE LESION AND INFLATED; HOWEVER, IT RUPTURED DURING ITS INITIAL INFLATION. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WITH NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING, THE PROTECTIVE BALLOON COVER, OR ANY OTHER STERILE PACKAGING COMPONENTS. AT THE TARGET SITE, THE VESSEL EXHIBITED SEVERE CALCIFICATION AND 100% STENOSIS, WITH NO ACUTE ANGLES OR BIFURCATIONS. THE ACCESS VESSEL SHOWED NO CALCIFICATION, TORTUOSITY, STENOSIS, ACUTE ANGLES, OR BIFURCATIONS. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPAR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22032008 ↗
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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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