Saber .035 48007010RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032080146), received between Feb 23, 2023 and May 13, 2025 — classified as 1 injury, 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.

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.

• MalfunctionMay 13, 2025Leak/Splash; Leak/Splash

  AS REPORTED, WHEN FLUSHING A 7MM X 100MM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WITH A SYRINGE, SALINE SQUIRTED OUT OF THE PROXIMAL PORTION OF THE BALLOON. AN UNKNOWN BALLOON CATHETER WAS USED AS A REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED A LEAKAGE THROUGH THE BODY/SHAFT OF THE SABER PTA BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013425 ↗
• InjuryFeb 23, 2023Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, THE BALLOON OF A 7MM X 10CM 135CM SABER .035 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER POPPED DUE TO SEVERE CALCIFICATION OF THE MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). NEGATIVE PRESSURE WAS THEN APPLIED TO THE DEVICE WITH AN INDEFLATOR SYRINGE AND BLOOD FILLED THE SYRINGE CONFIRMING THE RUPTURE. AFTER APPLYING NEGATIVE PRESSURE, THE DEVICE WAS RETRACTED THROUGH AN 8F CORDIS CATHETER SHEATH INTRODUCER (CSI). WHEN THE BALLOON WAS REMOVED, IT WAS NOTICED THAT THE ACTUAL BALLOON COATING WAS MISSING FROM THE BALLOON CATHETER. THE PHYSICIAN WAS UNABLE TO SEE THE SHEARED PORTION OF BALLOON UNDER FLUOROSCOPY AND THERE WAS CONCERN THAT THE BALLOON WAS SHEARED OFF THE BALLOON CATHETER WHEN RETRACTED INTO THE 8F UNKNOWN CORDIS CSI. THEREFORE, IT WAS DECIDED TO INTENTIONALLY CUT THE 8F CSI INTO MULTIPLE PIECES TO SEE IF THE SEPARATED BALLOON SEGMENT WAS WITHIN THE 8F CSI. THE SEPARATED BALLOON PORTION WAS EVENTUALLY OBSERVED INSIDE OF THE PATIENT. MULTIPLE ATTEMPTS WERE THEN MADE TO SNARE THE REMAINING BALLOON SEGMENT AND REMOVE IT FROM THE PATIENT BUT WERE UNSUCCESSFUL. AS A RESULT, A 7MM X 150MM SMART SELF-EXPANDING STENT (SES) AND AN 8MM X 40MM SMART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432625 ↗