SABER 48002002XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032069196), received between Mar 25, 2022 and Mar 25, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionMar 25, 2022Partial Blockage; Difficult to Advance; Material Integrity Problem; Partial Blockage; Difficult to Advance; Material Integrity Problem

  AS REPORTED, WHILE PERFORMING PRECONDITIONING TESTING FOR SABER OVER THE WIRE (OTW), AN OBSTRUCTION OF FOREIGN MATERIAL WAS FOUND INSIDE OF THE GUIDEWIRE LUMEN OF A 2MM X 2CM 150CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. AS MENTIONED, THIS WAS DURING PRECONDITIONING TESTING OF THE DEVICE AND THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL USE OF THE DEVICE. THE SAMPLE WAS SUCCESSFULLY FLUSHED; HOWEVER, DURING THE GUIDEWIRE INSERTION PORTION OF THE SAMPLE PREP, THE GUIDEWIRE FAILED TO PASS THROUGH THE LUMEN AND OUT OF THE HUB. UPON REVIEW OF THE DEVICE, AN OBSTRUCTION WAS SEEN IN THE LUMEN NEAR THE HUB. AN INFLATION DEVICE WITH FILTERED WATER WAS THEN USED TO FLUSH THE INJECTION LUMEN. I WAS REPORTED THAT 30 ATMOSPHERES (ATM) OF PRESSURE WAS REQUIRED TO DISLODGE THE OBSTRUCTING MATERIAL FROM THE BALLOON CATHETER. THE DEVICE ALONG WITH THE OBSTRUCTING MATERIAL WAS SENT TO THE ANALYTICAL LAB FOR FURTHER ANALYSIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904804 ↗

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