SABER 48003002SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032068502), received between Jun 13, 2019 and Mar 17, 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.

• MalfunctionMar 17, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3MM 2CM 90CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER COULD INFLATE IN ITS INITIAL INFLATION WITHOUT ANY ISSUES; HOWEVER, IT RUPTURED AT ITS SECOND INFLATION. THE MAXIMUM INFLATION PRESSURE WAS 8 ATMOSPHERES. THE BALLOON BURST AT 8 ATMOSPHERES. THEREFORE, IT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS DISCARDED IN THE HOSPITAL. THE LESIONS WERE AT BELOW-KNEE (BK) AND THE ANTERIOR TIBIAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO). AN IPSILATERAL APPROACH WAS MADE. THERE WAS NO ANOMALY NOTED TO THE PRODUCT PRIOR TO USE. 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 THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE DEVICE COULD BE DELIVERED TO THE LESION WITHOUT ANY ISSUES. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/F

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842743 ↗
• MalfunctionJun 13, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 3MM X 2CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED FOR PRE-DILATION, HOWEVER IT RUPTURED AT EIGHT ATMOSPHERES (ATM). NO PATIENT INJURY WAS REPORTED. THE LESION WAS A CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO. AN IPSILATERAL APPROACH WAS MADE. AN UNKNOWN GUIDEWIRE CROSSED THE LESION. AFTER THE SABER PTA BC RUPTURED, IT WAS REPLACED WITH A NEW, NON-CORDIS BC AND THE PROCEDURE WAS COMPLETED. THE DEVICE WAS DISCARDED DUE TO INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696590 ↗

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