Boston Scientific Recalls Lotus Edge Valve Systems Due to Release Failure Risk
Boston Scientific is recalling 386 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.
What this means for you
Illness, injury, or structural failure has been reported. 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 must be scored at least 4.
Plain-English summary
Boston Scientific Corporation is recalling 386 units of the Lotus Edge Valve System, a transcatheter aortic valve prosthesis premounted on a delivery system. The specific product affected is the 27mm sterile model, reference number H749LVS270, with GTIN 08714729940838. These devices were manufactured in Ireland and distributed to various U.S. states and foreign countries.
The recall was initiated because a 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, as the device may not deploy as intended.
The affected units include all unexpired lot numbers with expiration dates ranging from November 2, 2020, through October 29, 2021. Distribution was made to numerous U.S. states, including Alabama, Arizona, California, and Texas, as well as to government facilities and foreign countries such as Canada, Germany, and Japan. Healthcare providers and facilities that have received these devices should stop using them and contact Boston Scientific for further instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 386
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 08714729940838
- 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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