SABER 48002504SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032068427), received between Oct 17, 2019 and Oct 17, 2019 — classified as 1 malfunction.

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.

• MalfunctionOct 17, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING PERP, THE SABER BALLOON CATHETER RUPTURED AT TESTING AND DEFLATING OUTSIDE OF PATIENT. THERE WAS NO PATIENT INJURY. THERE WERE NO DIFFICULTIES REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS, THE PRODUCT FROM THE HOOP, OR THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED TO THE DEVICE. THE MALFUNCTION OCCURRED DURING PREP AND THE DEVICE WAS NOT USED IN THE PATIENT. AN UNKNOWN SYRINGE WAS USED INFLATION DEVICE. ANOTHER DEVICE WAS USED FOR TREATMENT. THE DEVICE IS BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202631 ↗

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