Saber .035 48007020RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032079478), received between Dec 12, 2025 and Dec 15, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Deflation Problem; Deflation Problem

  AS REPORTED, THE BALLOON OF A .035-INCH 7X200 135CM SABER .035 PTA DILATATION CATHETER WOULD NOT DEFLATE AFTER INFLATION TO NOMINAL PRESSURE. THE OPERATOR REMOVED THE .014 WIRE, LOSING WIRE ACCESS, AND INSERTED A .035 WIRE THROUGH THE LUMEN, AFTER WHICH THE BALLOON SLOWLY DEFLATED AND THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE HAD BEEN OPENED AND PREPARED IN THE STERILE FIELD PER THE INSTRUCTIONS FOR USE, WAS ADVANCED OVER A CORDIS ATW GUIDEWIRE TO THE TARGET LESION, AND RESISTANCE WAS FELT WHEN THE .035 WIRE WAS INSERTED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802616 ↗
• InjuryDec 12, 2025Deflation Problem; Deflation Problem

  AS REPORTED, AFTER BALLOON INFLATION OF A 7MM X 200MM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO NOMINAL PRESSURE FOR 30 SECONDS, THE OPERATOR ATTEMPTED TO DEFLATE THE BALLOON; HOWEVER, IT WOULD NOT DEFLATE. THE OPERATOR REMOVED THE INFLATION DEVICE AND ATTACHED A 20CC SYRINGE TO THE LUER HUB TO ATTEMPT TO DEFLATE BUT DEFLATION WAS UNSUCCESSFUL. THE OPERATOR DECIDED TO CUT AND REMOVE THE LUER HUB. AFTER SOME TIME, THE BALLOON SLOWLY DEFLATED AND WAS SAFELY REMOVED. AN 7MM X 200MM SABER .035 PTA BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THE DEVICE WAS OPENED AND PREPPED IN THE STERILE FIELD PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS INSERTED THROUGH AN UNKNOWN SHEATH AND OVER A 300CM STRAIGHT TIP FLOPPY ALL TRACK WIRE (ATW) GUIDEWIRE. AFTER INSERTION OF THE .014 GUIDEWIRE, THE WIRE WAS NOT EXCHANGED FOR AN .035 GUIDEWIRE BEFORE INFLATION, AND THE SABER .035 BALLOON CATHETER WAS INFLATED OVER THE .014 GUIDEWIRE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788394 ↗