Thin-Flex Single Stage Venous Drainage Cannula TF024O90Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103040937), received between Jul 29, 2025 and Feb 10, 2026 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Material Integrity Problem

  THE COMPLAINTS TEAM RECEIVED A REPORT WHERE THE USER WAS HAVING ISSUES WITH A TF024O90 CANNULA. DURING A CASE IT WAS NOTED THAT ON VACUUM SUCTION THE NON-WIRE REINFORCED COMPONENT (TIP) COLLAPSED AND SEEMS TOO EASILY COMPRESSIBLE. UPON REMOVAL, THE CANNULA WAS PANCAKED. THE USER HAD SOME QUESTION ON HOW WELL THE SUPERIOR VENA CAVA WAS ACTUALLY DRAINED DURING THE CASE. THIS CASE WAS DONE ON CARDIOPULMONARY BYPASS. NO DAMAGE TO THE PACKAGING/ TRAY WAS NOTED DURING PREPARATION. THE CARDIAC SURGEONS DO NOT FEEL IT IS SAFE TO USE. THE DEVICE WAS DISCARDED AT THE HOSPITAL. IMAGES WERE PROVIDED. ADDITIONAL INFORMATION RECEIVED: THE DEVICE WAS WORKING INITIALLY. THERE WERE NO ISSUES DURING DEVICE INSERTION OR PLACEMENT. THE DEVICE WAS PLACED IN THE SUPERIOR VENA CAVA. THE BYPASS TIME WAS JUST OVER THREE HOURS, BUT THE USER ALSO NOTED "THERE WAS NOW BLEEDING FROM THE SUPERIOR VENA CAVA CANNULATION SITE, AND THE HEART ACTUALLY TOLERATED A VOLUME LOAD RELATIVELY WELL AND CLAMPING OF THIS CANNULA, SO THIS CANNULA WAS REMOVED AND THE PURSESTRING WAS TIED. NO REPLACEMENT CANNULA WAS PLACED AFTER REMOVAL. THE USER REPORTEDLY STORES THE DEVICE PER THE IFU AND THERE IS NO ADDITIONAL PROCESSING AT T

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24306182 ↗
• MalfunctionNov 5, 2025Restricted Flow rate; Restricted Flow rate

  AS REPORTED BY OUR EDWARDS LIFESCIENCES JAPANESE AFFILIATE, A TF024O90 VENOUS CANNULA WAS EXCHANGED WITH A LARGER TF028O90 CANNULA DUE TO POOR VENOUS DRAINAGE AFTER THE INITIATION OF CARDIOPULMONARY BYPASS. THE OPERATION WAS COMPLETED WITH NO PATIENT ADVERSE EVENTS REPORTED. THE PATIENT'S OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479999 ↗
• MalfunctionJul 29, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  EDWARDS RECEIVED A REPORT OF AN EVENT (OR POSSIBLY A NUMBER OF EVENTS) WITH VENOUS CANNULAS. THE REPORTER SAID IT HAS BEEN WITH MULTIPLE SIZES OF CANNULAS, BUT THEY JUST DECIDED TO REPORT THE MOST RECENT CASE WHEN IT HAPPENED AGAIN. WHEN THEY TAKE THE CANNULA OUT FROM THE TRAY, IT SEEMS A PIECE OF PLASTIC BREAKS OFF AND STICKS TO THE CANNULA ITSELF. THE DEFECT WAS NOTED EITHER IN THE MIDDLE OF THE CASE OR THE END. PICTURES ARE INCLUDED IN THE CASE NOTES FOR THE CASE ON (B)(6). THE REPORTER ASKED IF SIMILAR EVENTS HAD BEEN REPORTED BY OTHER INSTITUTIONS. THIN FLEX SINGLE STAGE VENOUS DRAINAGE CANNULA 24FR, TF024O90, LOT#: 437704 IS SUSPECTED IN THE ON (B)(6) CASE. THE CANNULA WAS NOT RETAINED BUT THE PLASTIC PIECES WERE RETAINED FOR EVALUATION. THE CANNULA DID NOT APPEAR TO BE DAMAGED. THE PIECES WERE STILL ATTACHED TO THE CANNULA AFTER THE CASES OR REMOVED BEFOREHAND. THE CANNULA WAS USED IN THE PROCEDURE WITH NO IMPACT TO THE PATIENT REPORTED. NO IMPACT TO THE PROCEDURE REPORTED. STORED AT TEMPERATURE 23 C AND HUMIDITY OF 29%. PREVIOUS INSTANCES WERE ALSO MENTIONED, BUT NO INFORMATION WAS PROVIDED. AS THERE IS NO INFORMATION PERTAINING TO THE MODEL/ EVENT DATE FOR THE EVENT(S) PRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22654510 ↗

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