ThinFlex Single Stage Venous Drainage Cannula TF014O90Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103040739), received between Jul 31, 2025 and Jul 31, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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.

• MalfunctionJul 31, 2025Particulates; Manufacturing, Packaging or Shipping Problem; Particulates; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A 14FR TF014O90 CANNULA WAS FOUND TO HAVE A PIECE OF PLASTIC FROM THE TRAY BROKEN AND STUCK TO THE CANNULA BODY. IT SEEMED LIKE THE TRAY BROKE WHILE TAKING THE CANNULA OUT OF IT. THE PIECE OF STUCK PLASTIC WAS REPORTEDLY NOTED DURING OR TOWARDS THE END OF THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT OR THE PROCEDURE DUE TO THE REPORTED INCIDENT. THE CANNULA ITSELF WAS NOT DAMAGED. PER ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT NO PIECE(S) OF PLASTIC ATTACHED TO THE CANNULA ENTERED INTO THE PATIENT DURING USE. THE REPORTER STATED THAT THERE HAD BEEN SIMILAR CASES WITH MULTIPLE SIZES OF CANNULAS, BUT THE MOST RECENT CASES WERE REPORTED AFTER THE INCIDENT RECURRED. SEE 2025-18307-01 AND 2025-18307-02 FOR RELATED COMPLAINT INVESTIGATIONS. NO PICTURES WERE AVAILABLE FOR THIS DEVICE AND THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680864 ↗

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