Agency classClass IOur severity:Severe FDA (Devices)·Z-0736-2021·Announced 2021-01-20

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.

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 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
Hazard: device-malfunction
deployment-failure
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

Distributed in 38 states:

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 →

Same manufacturer · Boston Scientific Corporation

See all →

Severe
Boston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
Moderate
Boston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09

Same hazard · device malfunction