Thin-Flex Single Stage Venous Drainage Cannula TF028LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103041002), received between Sep 9, 2025 and Sep 9, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction 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.

• MalfunctionSep 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A TF028L VENOUS CANNULA WAS EXCHANGED WITH A LARGER TF030L CANNULA DUE TO POOR VENOUS DRAINAGE FOLLOWING THE INITIATION OF CARDIOPULMONARY BYPASS. THERE WERE NO PATIENT ADVERSE EVENTS REPORTED. THE PATIENT OUTCOME WAS REPORTED AS UNDER TREATMENT. PER THE REPORTED INFORMATION, THE DEVICE WAS USED DURING MITRAL VALVE REPLACEMENT AND CONCOMITANT CORONARY ARTERY BYPASS GRAFTING. THIS 28F SIZE WAS CHOSEN BASED ON THE PATIENT BODY BUILD AND ANATOMICAL CONSIDERATION WITHOUT ANY CONFUSION REGARDING THE RELATIONSHIP BETWEEN SIDE AND CORRESPONDING FLOW RATE. NO VISUAL ABNORMALITIES WERE OBSERVED IN THE PACKAGING PRIOR TO OPENING AND IN THE DEVICE ITSELF AFTER OPENING. DURING USE, THERE WAS NO KINKING OF THE CANNULA, AND NO EXTERNAL FORCE WAS APPLIED TO THE CANNULA. THE SURGEON AFFIRMED THAT THERE WAS NO MALFUNCTION OF THE DEVICE AND THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. HE COMMENTED THAT THE SMALL SIZE OF THE CANNULA WAS THE CAUSE OF THE INADEQUATE VENOUS DRAINAGE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23007665 ↗

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