Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Failure Risk
Boston Scientific is recalling 207 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device that could prevent the release of the delivery system during a critical procedure, meeting the rubric criteria for a structural vehicle/device defect or significant injury risk.
Plain-English summary
Boston Scientific Corporation is recalling 207 units of the Lotus Edge Valve System, a transcatheter aortic valve prosthesis premounted on a delivery system. The affected devices are 23mm, sterile, and manufactured in Ireland. The recall includes all unexpired lot numbers with expiration dates ranging from November 2, 2020, to October 29, 2021.
The recall was initiated because 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. This defect poses a risk to patients undergoing the procedure.
Distribution of the affected devices was made 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. Foreign distribution included 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.
The recalled product
- Product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 207
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 08714729940814
- All unexpired lot numbers
- expiration dates 2-Nov-2020 through 29-Oct-2021
Distribution
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.
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