ThinFlex Single Stage Venous Drainage Cannula TF010O90Recalls & reported problems

Edwards Lifesciences LLC · Single Stage Venous Return Cannula · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103040661), received between Apr 4, 2025 and Apr 4, 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Manufacturing, Packaging or Shipping Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 4, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
EDWARDS RECEIVED A REPORT WHERE THE SURGEON NOTICED THE NECK/ TIP OF A 10FR PLASTIC RIGHT-ANGLE CANNULA (TF010O90) WAS LONGER THAN USUAL. IT WAS NOT USED, AND A NEW TF010O90 WAS OPENED FROM A DIFFERENT LOT. IT IS AVAILABLE FOR RETURN AND IMAGES WERE PROVIDED. THERE WAS NO PATIENT INVOLVEMENT, AND IT WAS REPORTED THERE WAS NO IMPACT ON THE PROCEDURE. A RESPONSE HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21774592 ↗

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-3030-2018 · Mar 7, 2018 · Terminated
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), 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-0398-2016 · Nov 4, 2015 · Terminated
Thin-Flex Venous Cannula, Model Number:TF292902A

Device details

UDI-DI	`00690103040661`
Brand	ThinFlex Single Stage Venous Drainage Cannula
Model	TF010O90
Company	Edwards Lifesciences LLC
Product code	DWF · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Class	Class 2
FDA submission	K120072
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 19, 2024

Device type (GMDN): Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

A semi-rigid or rigid tube intended to be surgically inserted into the right atrium or large vein to serve as a channel for the extracorporeal transport of deoxygenated blood from a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as a venous cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.

Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices

DLP™ 77010
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
1 recall154 reports
EOPA™ 77422
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls19 reports
DLP™ 77008
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls9 reports
NA HY11W65R1
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls8 reports
DLP® 12113
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls6 reports
DLP® Aortic Root Cannula with Flow-Guard™ 11012
Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
2 recalls5 reports
EOPA™ 77622
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls4 reports
NA HY2V10R33
Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass
2 recalls3 reports

All CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page