SABER 48008006XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032069738), received between Dec 1, 2023 and Dec 1, 2023 — classified as 1 injury.

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

• InjuryDec 1, 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 AN 8MM X 6CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 10 ATMOSPHERES (ATM). THE RUPTURE WAS OBSERVED UNDER FLUOROSCOPY. WHEN ATTEMPTING TO WITHDRAW THE DEVICE INTO A 110CM BRITE TIP RADIANZ CATHETER SHEATH INTRODUCER (CSI), THERE WAS SOME RESISTANCE EXPERIENCED. FLUOROSCOPY REVEALED THAT A PIECE OF THE BALLOON WAS NEAR THE CSI AND POSSIBLY CAUGHT IN CALCIUM WITHIN THE ARTERY. THE BALLOON WAS REMOVED, AND IT APPEARED TO BE TORN AND MISSING A PART OF THE BALLOON PORTION. AN UNKNOWN SMART STENT WAS IMPLANTED TO TRAP THE DEBRIS AGAINST THE ARTERIAL WALL. THE TARGET LESION WAS THE RIGHT ILIAC ARTERY WHICH HAD SEVERE CALCIFICATION AND MILD TORTUOSITY. THE LESION WAS 90% STENOSED. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245329 ↗

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