Recall of Lotus Edge Valve System Transcatheter Aortic Valve Prosthesis Due to Deployment Locking Failure
Boston Scientific recalls 278 Lotus Edge Valve Systems due to a failure in visual inspection that prevents proper valve locking during deployment, potentially preventing delivery system release.
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 FDA Class I medical device with a functional failure that could prevent safe deployment of a life-critical procedure. Although no deaths or injuries are reported in the source text, the hazard represents a serious safety risk to patients undergoing transcatheter aortic valve interventions. Per the severity rubric, FDA Class I classifications require a minimum severity score of 4, and the presence of a functional failure in a critical medical device justifies this rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued Recall Number Z-0735-2021 for the Lotus Edge Valve System, a Transcatheter Aortic Valve Prosthesis Premounted on Delivery System (25mm, REF H749LVS250). The recall is based on a failure to execute the visual inspection correctly prior to locking the valve during deployment, which can lead to the inability to release the delivery system. This affects 278 devices distributed across multiple U.S. states and internationally to countries including Australia, Austria, Canada, and others. The manufacturer, Boston Scientific Corporation, is recalling all unexpired lot numbers with expiration dates ranging from November 2, 2020 through October 29, 2021.
Consumers and healthcare providers should immediately stop using any Lotus Edge Valve System with lot numbers covered by this recall. Affected devices were manufactured in Ireland by Boston Scientific Corporation and shipped to various locations nationwide and abroad. The recall is driven by a mechanical design flaw that compromises the ability to safely deploy the delivery system during transcatheter aortic valve procedures, posing a risk of incomplete or failed intervention.
All affected devices should be returned to the manufacturer or disposed of according to local regulations. Healthcare facilities should verify their inventory against the recall list and initiate corrective actions. Patients with previously implanted Lotus Edge Valve Systems should consult their cardiologist regarding the status of their device and follow any guidance provided by the manufacturer.
The recalled product
- Product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 278
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 08714729940821
- 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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