Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Defect
Boston Scientific is recalling 319 Lotus Edge Valve Systems because a visual inspection failure may 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 is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or higher.
Plain-English summary
Boston Scientific Corporation is recalling 319 units of the Lotus Edge Valve System, a transcatheter aortic valve prosthesis premounted on a delivery system (25mm, sterile, REF H749LVSUS250). The recall affects 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.
The devices were distributed to hospitals and government facilities in 37 U.S. states and the District of Columbia, as well as to 23 foreign countries including Australia, Canada, and several European nations. Healthcare providers should stop using these devices and contact Boston Scientific for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 319
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 08714729960911
- 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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