Thin-Flex Single Stage Venous Drainage Cannula TF028O90Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103041057), received between Feb 12, 2026 and Feb 12, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K120072); 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.

• MalfunctionFeb 12, 2026Contamination /Decontamination Problem; Difficult to Open or Remove Packaging Material

  EDWARDS RECEIVED NOTIFICATION FROM UNITED KINGDOM THAT UPON INSERTION OF A TF028O90 CANNULA WHILE GOING ON BYPASS, A SHARP PLASTIC FRAGMENT WAS OBSERVED ATTACHED TO THE TIP OF THE CANNULA. UPON IDENTIFICATION OF THE INCIDENT, THE CANNULA PACKAGING WAS INSPECTED, REVEALING DAMAGE TO THE PLASTIC PROTECTIVE COVER. PLASTIC MATERIAL FROM THE DAMAGED PROTECTIVE COVER WAS FOUND TO BE ADHERENT TO THE CANNULA. PER RESPONSE RECEIVED, THE USERS OPINION WAS THAT THIS DEFECT POSED A POTENTIAL RISK OF INJURY TO THE PATIENT AS WELL AS TO HEALTHCARE PERSONNEL HANDLING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322747 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120072. One submission often covers many models, so check the product and lot details in each record.

• Z-3029-2018 · Mar 7, 2018 · Terminated
  Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
• Z-3031-2018 · Mar 7, 2018 · Terminated
  Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
• Z-3030-2018 · Mar 7, 2018 · Terminated
  Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
• Z-0398-2016 · Nov 4, 2015 · Terminated
  Thin-Flex Venous Cannula, Model Number:TF292902A