Cardiac Assist TandemLife ECLS Kit V24/A17: Wrong Cannula May Cause Blood Flow Issues
Cardiac Assist recalls TandemLife ECLS Procedure Kit V24/A17 (Catalog 5740-2417) due to incorrect cannula size. This kit contains a 29Fr ProtekDuo instead of the required 24Fr ProtekSolo, which could lead to improper blood flow during cardiac support procedures.
Lower-risk recall
The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
Contact the company
What happened, in plain English
Cardiac Assist is recalling TandemLife ECLS Procedure Kit V24/A17 (Catalog 5740-2417) because it includes a 29Fr ProtekDuo cannula instead of the correct 24Fr ProtekSolo. This mismatch could cause improper blood flow during critical cardiac support procedures, potentially leading to complications for patients. Read more at govinfonow.com/recall/66498-cardiac-assist-tandemlife-ecls-kit-v24-a17-wrong-cannula-may.
Source Summary by GovInfoNow · govinfonow.com/recall/66498-cardiac-assist-tandemlife-ecls-kit-v24-a17-wrong-cannula-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1106-2020
Cite this page
“Cardiac Assist TandemLife ECLS Kit V24/A17: Wrong Cannula May Cause Blood Flow Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66498-cardiac-assist-tandemlife-ecls-kit-v24-a17-wrong-cannula-may. Based on FDA recall #Z-1106-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1106-2020%22&limit=1).
Why it’s dangerous
The kit contains a 29Fr ProtekDuo cannula instead of the required 24Fr ProtekSolo. This size mismatch could lead to improper blood flow when connected to extracorporeal circulatory support equipment, potentially causing complications during cardiac procedures.
Who’s affected
Healthcare professionals using the TandemLife ECLS Procedure Kit V24/A17 for cardiac support. Patients receiving this equipment are at risk if the incorrect cannula causes improper blood flow during procedures.
How to tell if you have this one
Check for the product name 'TandemLife ECLS Procedure Kit V24/A17' with catalog number 5740-2417. The kit includes serial numbers starting with 141445 to 141454 and 141457. The expiration date for all products is August 25, 2020.
- Brand
Cardiac Assist- Product
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417- Category
Medical device
What to do — step by step
Check Product Details
Verify the product name, catalog number, and serial numbers to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “US Nationwide distribution in the states of AZ, AL, ME, LA, PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Louisiana, Maine, Pennsylvania.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1106-2020 (November 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1106-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.