Edwards Lifesciences Vent Catheter E063Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103030907), received between Jan 7, 2022 and Jan 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

1 other recall cover devices cleared under the same FDA submission (K113411); 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 18, 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.

• MalfunctionJan 7, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  EDWARDS RECEIVED NOTIFICATION THAT A HAIR WAS NOTICED ON THE TIP OF THIS VENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195439 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113411. One submission often covers many models, so check the product and lot details in each record.

• Z-0217-2015 · Oct 8, 2014 · Terminated
  Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended