Edwards Certitude Delivery System Recall: Molding Overflow Risk
Edwards Lifesciences recalls Certitude Delivery System models 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A due to potential molding overflow defect that could detach during use and embolize into the patient.
Use caution until it’s fixed
A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
Contact the company
What happened, in plain English
Edwards Lifesciences is recalling specific Certitude Delivery System models (9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A) because a component may have a molding overflow defect that could detach during use and potentially embolize into the patient. This risk occurs during transcatheter aortic valve replacement procedures. Read more at govinfonow.com/recall/73383-edwards-certitude-delivery-system-recall-molding-overflow-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73383-edwards-certitude-delivery-system-recall-molding-overflow-risk · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0293-2018
Cite this page
“Edwards Certitude Delivery System Recall: Molding Overflow Risk.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73383-edwards-certitude-delivery-system-recall-molding-overflow-risk. Based on FDA recall #Z-0293-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0293-2018%22&limit=1).
Why it’s dangerous
The Certitude Loader component may have a molding overflow defect that could detach during advancement of the delivery system. If detached, it could potentially embolize from the loader into the patient's bloodstream, causing serious complications during heart valve replacement procedures.
Who’s affected
Patients who have received the recalled Certitude Delivery System models for transcatheter aortic valve replacement procedures are at risk. Medical professionals using these devices during procedures may also be affected.
How to tell if you have this one
Check if your Certitude Delivery System includes models 9600CT20A, 9600CT23A, 9600CT26A, or 9600CT29A. These are used with Edwards SAPIEN 3 transcatheter heart valves during transapical or transaortic approaches to valve replacement.
- Brand
Edwards Lifesciences- Category
Medical device
What to do — step by step
Check Product Model
Identify if your Certitude Delivery System is one of the recalled models (9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A).
Contact Edwards Lifesciences
Reach out to Edwards Lifesciences for guidance on next steps if you have a recalled model.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0293-2018 (July 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0293-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 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.