SABER 48005010XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032068144), received between Aug 4, 2020 and Jan 13, 2023 — 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 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.

• MalfunctionJan 13, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AFTER INSERTION OF A 5MM X 10CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, AN ATTEMPT TO INFLATE THE BALLOON WAS MADE BUT THE BALLOON WAS NOT SEEN INFLATING UNDER FLUOROSCOPY. THE DEVICE WAS REMOVED, AND A SECOND 5MM X 10CM 150CM SABER PTA BALLOON CATHETER WAS INSERTED. UPON INFLATION OF THE SECOND SABER PTA BALLOON CATHETER, THE SAME ISSUE OCCURRED WHERE THE BALLOON WAS NOT SEEN INFLATING UNDER FLUOROSCOPY. THERE WAS A POSSIBILITY THAT THE BALLOONS HAD RUPTURED DUE TO THE PRESENCE OF EXCESSIVE CALCIFICATION AT THE TARGET SUPERFICIAL FEMORAL ARTERY (SFA) LESION; HOWEVER, THIS WAS NOT CONFIRMED. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED A RUPTURE TO THE BALLOON OF THE FIRST SABER PTA BALLOON CATHETER USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156655 ↗
• MalfunctionJan 8, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE MID PART OF THE BALLOON OF A 5MM X 10CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN A STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139500 ↗
• MalfunctionAug 4, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 5MM X 10CM X 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FILLED IN THE PATIENT¿S BODY FOR TWO MINUTES AND THEN IT BURST. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10361428 ↗

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