Use caution Medical device recall · FDA · Published January 22, 2019

Edwards Commander Delivery System Recall: Balloon Component Separation Risk

Recall of Edwards Commander Delivery System models due to reported balloon component separation during TAVR procedures. Affected units include specific model numbers and UDI numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0835-2019Medical device Edwards Lifesciences ›

Use caution until it’s fixed

This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

Take action

Contact the company

Recalling firmEdwards Lifesciences, LLC12050 S Lone Peak Pkwy · Draper, UT 84020-9414

✎ GovInfoNow plain-language explainer

Edwards Lifesciences is recalling its Commander Delivery System for potential balloon component separation during TAVR procedures. This could lead to complications during heart valve replacement surgery. Read more at govinfonow.com/recall/69093-edwards-commander-delivery-system-recall-balloon-component-separation-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/69093-edwards-commander-delivery-system-recall-balloon-component-separation-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0835-2019

Cite this page

“Edwards Commander Delivery System Recall: Balloon Component Separation Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69093-edwards-commander-delivery-system-recall-balloon-component-separation-risk. Based on FDA recall #Z-0835-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0835-2019%22&limit=1).

The FDA announced on Jan. 22, 2019, that Edwards Lifesciences, LLC is voluntarily recalling the Edwards Commander Delivery System due to component separation risks during procedures. The agency issued recall number Z-0835-2019 for the Class II device.

How to tell if you have it

Brand: Edwards Lifesciences
Product: Edwards Commander Delivery System
Model Numbers/UDI: 9600LDS20A (US) 00690103193930, 9600LDS20J 00690103194852, 9600LDS23A (US) 00690103193947, 9600LDS23J 00690103194869, 9600LDS26A (US) 00690103193954, 9600LDS26J 00690103194876, 9600LDS29A (US) 00690103193961, 9600LDS29J 00690103194883, 9610TF20 00690103192995, 9610TF23 00690103190458, 9610TF26 00690103190465, 9610TF29 00690103193008
Units affected: 159,448

The hazard

The recall addresses complaints of crimp balloon and inflation balloon component separation during TAVR procedures. The FDA initiated the action to address these specific complaint reports.

Context

GovInfoNow's records show Edwards Lifesciences, LLC has 25 other recalls on record since July 6, 2017. Other recent recalls of similar products include Edwards EVOQUE Tricuspid Delivery System Recall (March 27, 2026), Edwards Optisite Arterial Cannula Recall (May 14, 2025), and Edwards Lifesciences Acumen IQ Sensor Recall (Oct. 4, 2023). Other recent recalls of similar products include Diversatek Viper 3-Stage Balloon Dilator Recall (March 18, 2026), Merit Medical Allwell Angioplasty Pack Recall (Dec. 4, 2025), and Medline convenience kits with Olympus biopsy valves recalled (Feb. 16, 2026).

How to tell if you have this one

Check the model number and UDI number on the product label. Affected models include 9600LDS20A, 9600LDS20J, 9600LDS23A, 9600LDS23J, 9600LDS26A, 9600LDS26J, 9600LDS29A, 9600LDS29J, 9610TF20, 9610TF23, 9610TF26, and 9610TF29 with specific UDI numbers.

Brand
Edwards Lifesciences
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the model number and UDI number on the product label to determine if it is affected.
Contact Manufacturer
Contact Edwards Lifesciences directly to confirm if your specific model is affected and to get further instructions.

How this recall unfolded

Recall timeline

FDA terminated this recall 2 months after the firm started it.

Jan 22, 2019Firm started the recall
Feb 14, 2019FDA classified it Class II
Feb 20, 2019Published in FDA’s Enforcement Report
Mar 26, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this product immediately?

The recall does not require immediate stop use; however, affected users should check their product label and contact Edwards Lifesciences to confirm if their model is affected.

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Link to this recall

<a href="https://govinfonow.com/recall/69093-edwards-commander-delivery-system-recall-balloon-component-separation-risk">Edwards Commander Delivery System Recall: Balloon Component Separation Risk (GovInfoNow)</a>

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-0835-2019 (January 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0835-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 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.