Boston Scientific Lotus Edge Valve System Recall: Deployment Failure Risk
Boston Scientific recalls Lotus Edge Valve System (23mm) due to risk of deployment failure if visual inspection is skipped during valve locking. Affected units have specific lot numbers and expiration dates.
Use caution until it’s fixed
Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.
Contact the company
What happened, in plain English
Boston Scientific is recalling its Lotus Edge Valve System (23mm) because improper visual inspection before locking the valve during deployment can cause the delivery system to become stuck. This could prevent the valve from being released properly, potentially causing complications during medical procedures. Read more at govinfonow.com/recall/63900-boston-scientific-lotus-edge-valve-system-recall-deployment-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63900-boston-scientific-lotus-edge-valve-system-recall-deployment-failure-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0728-2021
Cite this page
“Boston Scientific Lotus Edge Valve System Recall: Deployment Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63900-boston-scientific-lotus-edge-valve-system-recall-deployment-failure-risk. Based on FDA recall #Z-0728-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0728-2021%22&limit=1).
Why it’s dangerous
The valve system requires a visual check before locking to ensure the delivery system can be released after deployment. If this check is skipped, the delivery system may become stuck, preventing the valve from being properly released and potentially causing complications during the procedure.
Who’s affected
Patients undergoing aortic valve replacement procedures who use the recalled Lotus Edge Valve System. Medical professionals performing the procedure are most at risk if they use the affected units.
How to tell if you have this one
Check for the product name 'Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile' with the specific GTIN 08714729960904. Affected units have expiration dates from November 2, 2020, through October 29, 2021.
- Brand
Boston Scientific- Product
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF- Category
Medical device
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. Government distribution was also made. Foreign distribution was made to Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, South Korea, Spain, Sweden, and Switzerland.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0728-2021 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904; GTIN 08714729960904. All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021 | 219 devices |
| Z-0729-2021 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ireland.; GTIN 08714729960911, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021 | 319 devices |
| Z-0730-2021 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, Made in Ireland, Ballybrit Business Park, Galway, Ireland.; GTIN 08714729960928, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021 | 302 devices |
| Z-0734-2021 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.; GTIN 08714729940814, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021 | 207 devices |
| Z-0735-2021 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.; GTIN 08714729940821, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021 | 278 devices |
| Z-0736-2021 | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.; GTIN 08714729940838, All unexpired lot numbers, expiration dates 2-Nov-2020 through 29-Oct-2021 | 386 devices |
What to do — step by step
Check Product Details
Identify the product name and GTIN 08714729960904 to confirm if your unit is affected.
Contact Provider
Reach out to your healthcare provider to discuss whether the valve system needs to be replaced or adjusted.
Where it went and when
Where it was distributed
Distributed in 37 states and D.C., and outside the U.S.
FDA distribution: “Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. Government distribution was also made. Foreign…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 14 months 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-0728-2021 (November 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0728-2021 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.