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.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
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
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 →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · deployment failure
See all →- SevereGORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall
FDA (Devices) · 2026-07-08
- HighCGuard Prime 9mm by 30mm carotid stents may fail deployment
FDA (Devices) · 2026-06-17
- HighCGuard Prime 8mm by 30mm carotid stents may fail deployment
FDA (Devices) · 2026-06-17
- HighCGuard Prime 10mm by 30mm carotid stents may fail deployment
FDA (Devices) · 2026-06-17
- HighCGuard Prime 9mm carotid stent systems may resist or fail deployment
FDA (Devices) · 2026-06-17
Similar recalls
- SevereBoston Scientific Recalls Lotus TAVR 27mm Transcatheter Aortic Valve Prosthesis
FDA (Devices) · 2015-01-21
- SevereBoston Scientific Recalls Lotus TAVR 23mm Transcatheter Aortic Valve Prosthesis
FDA (Devices) · 2015-01-21
- SevereBoston Scientific Recalls Lotus TAVR Valve Prosthesis Due to Unlocking Risk
FDA (Devices) · 2015-01-21
- ModerateBoston Scientific Recalls Stretch VL Ureteral Stent Sets Due to Tracking Issues
FDA (Devices) · 2020-04-29
- HighBoston Scientific Recalls Contour VL Ureteral Stent Sets
FDA (Devices) · 2020-04-29
- HighBoston Scientific Recalls Stretch VL Ureteral Stent Sets
FDA (Devices) · 2020-04-29