SABER 48004006XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032069455), received between Aug 3, 2020 and Oct 19, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 4MM X 6CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR PRE-EXPANSION; HOWEVER, THE BALLOON RUPTURED AT 10 ATMOSPHERES (ATM) AND THE BLOCK SECTION HAS NOT BEEN EXPANDED. THEREFORE, IT WAS REPLACED WITH THE SAME SIZE SABER BALLOON TO PRE-EXPAND THE LESION. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE RIGHT ILIAC ARTERY WITH 4-5CM OCCLUSION. THE INTENDED PROCEDURE WAS TO IMPLANT A BALLOON DILATATION STENT. A PUNCTURE WAS DONE AT FEMORAL ARTERY, A NON-CORDIS SHEATH WAS INSERTED AND OPENED A BLOCK SECTION WITH A NON-CORDIS GUIDEWIRE AND THE BALLOON WAS EXPANDED STEP BY STEP. THE NOMINAL RATED BURST PRESSURE (RBP) OF THE BALLOON WAS 18 ATM. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10700622 ↗
• MalfunctionAug 3, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF 4MM X 6CM X 150CM SABER BALLOON CATHETER RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED PER LABELLING AND OPENED IN STERILE FIELD. THE DEVICE WILL BE RETURNED FOR ANALYSIS. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE AND HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10355758 ↗

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