SABER 48007008XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032069691), received between Apr 12, 2024 and Apr 12, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, DURING A PERIPHERAL INTERVENTION OF A HEAVILY CALCIFIED VESSEL THE 7MM 8CM SABER BALLOON CATHETER WAS USED TO PRE-DILATE THE TRACT. THE BALLOON CATHETER CROSSED THE LESION EASILY FOR THE INITIAL INFLATION. THE BALLOON WAS DEFLATED AND MOVED AND RE-INFLATED TO TREAT ANOTHER PORTION OF THE VESSEL. THE BALLOON WAS DEFLATED SUCCESSFULLY AND DURING THE REMOVAL OF THE BALLOON RESISTANCE WAS MET AND THE BALLOON CATHETER BROKE INSIDE THE PATIENT. THE MD WAS ABLE TO REMOVE MOST OF THE CATHETER, BUT A PORTION OF THE WIRE LUMEN AND BALLOON MATERIAL WAS LEFT INSIDE THE PATIENT INCLUDING THE PROXIMAL AND DISTAL RADIOPAQUE MARKERS. SOME OF THIS WAS ABLE TO BE REMOVED USING A SNARE CATHETER BUT THE OTHER PORTION REMAINED INSIDE THE PATIENT AND A COVERED STENT WAS PLACED TO CAPTURE THE REMAINING BALLOON MATERIAL AGAINST THE VESSEL WALL TO PREVENT EMBOLIZATION AND MIGRATION OF THE RETAINED PORTION. THE PROCEDURE WAS COMPLETED USING CONTRALATERAL FEMORAL ACCESS. THE DEVICE WAS STORED PROPERLY PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP, WHILE REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19100999 ↗

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