ThinFlex Single Stage Venous Drainage Cannula TF022O90Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103040890), received between Aug 6, 2025 and Aug 7, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Particulates; Manufacturing, Packaging or Shipping Problem; Particulates; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A TF022O90 VENOUS CANNULA WAS FOUND TO HAVE AN EXTRA PIECE OF PLASTIC DISTALLY, AT THE END OF THE WIRE BODY, BEFORE PLACING THE DEVICE IN THE PATIENT. THE SURGEON DECIDED TO MOVE FORWARD WITH USING THE DEVICE FOR A PVAC PROCEDURE. THE EXTRA PLASTIC PIECE WAS NOT REMOVED BY THE SURGEON PRIOR TO USE. THERE WAS NO IMPACT TO THE PATIENT OR THE PROCEDURE AS A RESULT OF THIS INCIDENT. PER ADDITIONAL INFO RECEIVED, THE REMAINING CANNULAS IN THE HOSPITAL INVENTORY BELONGING TO THE AFFECTED LOT WERE CHECKED AND THEY APPEARED FINE. THE DEVICES ARE LOOSELY STORED IN A BIN UNDER NORMAL HOSPITAL TEMPERATURE. THE TRAY IN WHICH THE CANNULA IS SEATED (PART OF PACKAGING) WAS STATED TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734903 ↗
• MalfunctionAug 6, 2025Particulates; Dent in Material; Manufacturing, Packaging or Shipping Problem; Particulates; Dent in Material; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A TF022O90 VENOUS CANNULA WAS FOUND TO HAVE AN EXTRA PIECE OF PLASTIC DISTALLY, AT THE END OF THE WIRE BODY, BEFORE PLACING THE DEVICE IN THE PATIENT. THE SURGEON DECIDED TO MOVE FORWARD WITH USING THE DEVICE FOR A FONTAN PROCEDURE AND PLUCKED OFF THE PLASTIC AFTER THE CASE WAS OVER. THERE WAS NO IMPACT TO THE PATIENT OR THE PROCEDURE AS A RESULT OF THIS INCIDENT. THE TRAY WAS STATED TO BE INTACT. PER ADDITIONAL INFO RECEIVED, THE REMAINING CANNULAS IN THE HOSPITAL INVENTORY BELONGING TO THE AFFECTED LOT WERE CHECKED AND THEY APPEARED FINE. THE DEVICES ARE LOOSELY STORED IN A BIN UNDER NORMAL HOSPITAL TEMPERATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734218 ↗

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