enableCV Thin-Flex™ Single Stage Venous Drainage Cannula TF024O90Recalls & reported problems
Enablecv Inc. · enableCV Thin-Flex™ Single Stage Venous Drainage Cannula - TF024O90 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840479400716), received between Jul 29, 2026 and Aug 12, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (3 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.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem3
- Deformation Due to Compressive Stress2
Patient problems
- Reduced Blood Flow3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Deformation Due to Compressive Stress; Infusion or Flow Problem
Patient problems: Reduced Blood Flow
MAUDE report 50224542 ↗MalfunctionAug 6, 2026Deformation Due to Compressive Stress; Infusion or Flow Problem
Patient problems: Reduced Blood Flow
MAUDE report 50161434 ↗MalfunctionJul 29, 2026Infusion or Flow Problem
Patient problems: Reduced Blood Flow
MAUDE report 50075735 ↗
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 · TerminatedEdwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
- Z-3029-2018 · Mar 7, 2018 · TerminatedEdwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
- Z-3031-2018 · Mar 7, 2018 · TerminatedEdwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
- Z-0398-2016 · Nov 4, 2015 · TerminatedThin-Flex Venous Cannula, Model Number:TF292902A
Other Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass devices
- DLP™ 77010Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
- EOPA™ 77422Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY2V10R33Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
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