SABER 48006002SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032068724), received between Jun 18, 2019 and Jun 14, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 16, 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.

• MalfunctionJun 14, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A 6MM2CM SABER BALLOON WAS DEFECTIVE AND CAUSED AN ISSUE DURING A CASE TODAY. THE BALLOON WAS INFLATED WITHIN A STENT IN A PULMONARY VEIN. THE BALLOON WOULD NOT DEFLATE. THE CATHETER WAS NOTED TO HAVE A HOLE THAT WAS PREVENTING DEFLATION. A 7X2 SABER AND A 6X2 SABER BALLOON WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE PACKAGE GENE COMPONENTS. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS NOTED TO HAVE NO CALCIFICATION AND NO VESSEL TORTUOSITY. THAT DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING A BALLOON THROUGH THE UNKNOWN GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION WITH THE BALLOON. THE CATHETER WAS NEVER IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537490 ↗
• MalfunctionJul 2, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A SABER BALLOON CATHETER (6MM2CM 90) WAS DELIVERED TO THE LESION IN THE SUPERFICIAL FEMORAL ARTERY AND INFLATED, HOWEVER, THE BALLOON RUPTURED WITHIN ITS NOMINAL PRESSURE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED AND WILL NOT BE RETURNED OR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8752907 ↗
• MalfunctionJun 18, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 6MMX2CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS INSERTED AND INFLATED, HOWEVER IT RUPTURED DUE TO HEAVY CALCIFICATION. NO PATIENT INJURY WAS REPORTED. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PERCENTAGE OF STENOSIS WAS SEVENTY PERCENT AND IT WAS NOT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS MODERATE VESSEL ANGULATION. THE DEVICE WAS STORED, HANDLED, INSPECTED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND THE DEVICE PREPPED NORMALLY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER, AND NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE BALLOON CATHETER REMOVED EASILY AND INTACT (IN ONE PIECE) FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW NON-CORDIS BALLOON CATHETER. THE DEVICE WAS DISCARDED BY MISTAKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707081 ↗

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