SABER 48003002XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032069301), received between Nov 7, 2019 and Mar 17, 2020 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2020Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, AN UNKNOWN WIRE COULD NOT CROSS A 3MM X 2CM SABER 150 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). DURING FAL ANALYSIS IT WAS NOTED THAT A GUIDEWIRE PUNCTURED THROUGH THE GUIDEWIRE LUMEN. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE LOOKED NORMAL WHEN TAKEN FROM ITS PACKAGING. THERE WAS NO DIFFICULTY EXPERIENCED WHEN REMOVING THE BALLOON CATHETER FROM THE PACKAGING. THE PRODUCT WAS STORED, HANDLED AND INSPECTED AS PER INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY FLUSHING THE BALLOON CATHETER WITH SALINE. A NON-CORDIS GUIDEWIRE WAS USED. THE MALFUNCTION OCCURRED IN PATIENT. THE WIRE AND CATHETER CROSSED ACUTE BENDS IN THE VESSEL TO PROCEED IN THE PROCEDURE. THE CATHETER DID NOT ADVANCE TOTALLY OVER THE WIRE. THE SAME NON-CORDIS GUIDEWIRE WAS USED WITH THE NEW DEVICE. THE LUMEN WAS PROPERLY FLUSHED. THE WIRE WAS FLUSHED AND/OR WIPED DOWN PRIOR TO ATTEMPTING TO LOAD THE DEVICE ONTO IT. THE DEVICE WAS FLUSHED EVERY TIME PRIOR TO LOADING THE BALLOON ONTO THE GUIDEWIRE. THE DEVICE WAS LOADED FROM DISTAL TO PROXIMAL. THE DEVICE WILL BE RETURNED FOR ANALYSIS. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842603 ↗
• MalfunctionNov 7, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 3MM 2CM 150 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON WAS UNABLE TO BE INFLATED DURING THE PREP STAGE. PER MICROSCOPIC ANALYSIS, SCANNING ELECTRON MICROSCOPY (SEM) RESULTS SHOWS THAT THE BALLOON LEAKAGE WAS CAUSED BY A RUPTURE ON THE BALLOON SURFACE. THE INNER SURFACE PRESENTED ELONGATIONS ALONG THE RUPTURE. THE OUTER SURFACE PRESENTED EVIDENCE OF SCRATCH MARKS NEAR TO THE BALLOON RUPTURE. THE INTENDED PROCEDURE WAS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE TARGET LESION WAS THE POPLITEAL ARTERY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU. 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. THE PROCEDURE WAS COMPLETED WITH A NON-CORDIS DEVICE. THERE WAS NO REPORTED PATIENT INJURY. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292184 ↗

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