SABER 48007003XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032069660), received between Feb 24, 2021 and Feb 24, 2021 — 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.

• MalfunctionFeb 24, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  UPON BALLOONING A SEVERELY CALCIFIED LEFT COMMON FEMORAL ARTERY AT THE PROXIMAL ANASTOMOSIS OF THE STENTED AREA OF A BYPASS GRAFT, A 7MM X 3CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED TO 13 ATMOSPHERES (ATM); HOWEVER, IT BURST AND THE WHOLE BALLOON SEGMENT SEPARATED FROM THE DELIVERY CATHETER SYSTEM ON A .018 NON-CORDIS GUIDEWIRE. THE BALLOON SEPARATED FROM THE SHAFT ON THE .018 NON-CORDIS GUIDEWIRE V18 . THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT IN 2 PIECES. THE SEPARATED SEGMENT WAS REMOVED BY THE WIRE THROUGH THE SHEATH.THE STATUS OF THE PATIENT IS STABLE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD.THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREP NORMALLY. THE CONTRAST TO SALINE RATIO WAS 50/50. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372636 ↗

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