SABER 48007010XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032069707), received between Dec 20, 2021 and Mar 10, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K133843); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF TWO SABER 7MM 10CM BURST WHEN ATTEMPTING TO INFLATE INSIDE A PLACED STENT (UNKNOWN). THE CASE WAS COMPLETED WITH THE USE OF A POWERFLEX PRO 7X100MM BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE BALLOONS WERE NOTED TO HAVE BURST BELOW THE RATED BURST PRESSURE (RBP). THE PRODUCTS WERE STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, AND/OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS PREPPED NORMALLY. THE BALLOON WAS ABLE TO HOLD AND MAINTAIN NEGATIVE PRESSURE. THE INTENDED LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY THAT WAS NOTED TO HAVE A CALCIFICATION. ATHERECTOMY WAS USED PRIOR, THEN STENTED. THE DEVICES WERE NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE VESSEL WAS NOTED TO HAVE NO TORTUOSITY. THE INFLATION DEVICE WAS FILLED WITH ¼ CONTRAST TO ¾ SALINE. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES DURING PROCEDURE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13723956 ↗
• MalfunctionMar 10, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOONS OF TWO SABER 7MM 10CM BURST WHEN ATTEMPTING TO INFLATE INSIDE A PLACED STENT (UNKNOWN). THE CASE WAS COMPLETED WITH THE USE OF A POWERFLEX PRO 7X100MM BALLOON. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE BALLOONS WERE NOTED TO HAVE BURST BELOW THE RATED BURST PRESSURE (RBP). THE PRODUCTS WERE STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, AND/OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS PREPPED NORMALLY. THE BALLOON WAS ABLE TO HOLD AND MAINTAIN NEGATIVE PRESSURE. THE INTENDED LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY THAT WAS NOTED TO HAVE A CALCIFICATION. ATHERECTOMY WAS USED PRIOR, THEN STENTED. THE DEVICES WERE NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE VESSEL WAS NOTED TO HAVE NO TORTUOSITY. THE INFLATION DEVICE WAS FILLED WITH ¼ CONTRAST TO ¾ SALINE. THE SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES DURING PROCEDURE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13723901 ↗
• MalfunctionDec 20, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 7MM X 10CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING INFLATION OF A CALCIFIED PERIPHERAL LESION. THE BALLOON CATHETER WAS REMOVED EASILY FROM THE PATIENT, IT REMAINED IN ONE PIECE DURING REMOVAL, AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS, AND THERE WERE NO KINKS TO THE DEVICE NOTED PRIOR TO INSERTION. THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION AND THE CONTRAST USED FOR THE PROCEDURE WAS OMNIPAQUE 300. THERE WAS NO DIFFICULTY EXPERIENCED WHILE THE SABER PTA BALLOON CATHETER CROSSED THE LESION AND A MIXTURE OF 1/3 CONTRAST AND 2/3 SALINE WAS USED TO INFLATE THE BALLOON TO NOMINAL PRESSURE WHEN IT BURST. INFORMATION ON THE COMPLETION OF THE PROCEDURE WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13047414 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133843. One submission often covers many models, so check the product and lot details in each record.

• Z-2235-2021 · Jul 19, 2021 · Terminated
  Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X