SABER 48009006SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032068977), received between Apr 16, 2021 and Apr 16, 2021 — 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.

• InjuryApr 16, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AS REPORTED, A 9MM X 6CM 90 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST AND BROKE OFF. THE BALLOON CATHETER WAS NOT REMOVED EASILY, IT HAD TO BE SNARED, IT WAS REMOVED IN TWO PIECES. THERE WAS NO REPORTED PATIENT INJURY. IT WAS USED IN A COVERED STENT FOR AN IN-STENT RESTENOSIS. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD. THE DEVICE WAS STORED IN THE OPERATING ROOM FOR FOUR MONTHS. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE CONTRAST TO SALINE RATIO WAS 50:50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THERE WAS NO DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE SHEATH. THERE WERE STENTS PRESENT WITHIN THE TREATMENT SITE OR TRACKING PATH. THE TARGET WAS INSTENT RESTEONIS OF A STENT. THE LESION WAS NOT CALCIFIED OR TORTUOSITY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11678296 ↗

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