The Recall Desk
HighFDA (Devices)·Z-0730-2021·Announced 2021-01-20

Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Failure Risk

Boston Scientific is recalling 302 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a defect could lead to the inability to release the delivery system during deployment. While no specific injuries or illnesses are reported in the source text, the potential for serious harm during a surgical procedure places this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 302 units of the Lotus Edge Valve System, a transcatheter aortic valve prosthesis premounted on a delivery system. The specific product reference is H749LVSUS270, and the devices are sterile, 27mm in size, and manufactured in Ireland. The recall covers all unexpired lot numbers with expiration dates ranging from November 2, 2020, to October 29, 2021.

The recall was initiated because a failure to correctly execute the visual inspection prior to locking the valve during the deployment process can lead to the inability to release the delivery system. This defect poses a risk to patients undergoing the procedure, as the device may not function as intended during the critical deployment phase.

The affected devices were distributed to numerous U.S. states, including Alabama, Arkansas, Arizona, California, Colorado, the District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. Government distribution was also made. Additionally, the devices were distributed to foreign countries including Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Luxembourg, the Netherlands, Norway, Poland, Portugal, South Korea, Spain, Sweden, and Switzerland.

Healthcare providers and facilities that have received these devices should stop using them immediately and contact Boston Scientific for instructions on how to return or dispose of the product. Patients who have already undergone the procedure should consult their healthcare provider if they have concerns regarding the device's performance.

The recalled product

Product
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.
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiovascular
Hazard
Affected units
302

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • GTIN 08714729960928
  • All unexpired lot numbers
  • expiration dates 2-Nov-2020 through 29-Oct-2021

Distribution

Distributed in 38 states:

Part of a larger recall action

This product is one of 6 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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Same hazard · deployment failure

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