Boston Scientific Recalls Lotus TAVR 27mm Transcatheter Aortic Valve Prosthesis
Boston Scientific is recalling 278 units of the Lotus TAVR 27mm valve because the device may unlock during release, potentially causing the valve to embolize.
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 structural defect in a medical device that could lead to valve embolization and the need for surgical conversion, which constitutes a significant injury risk under the rubric for Severe recalls.
Plain-English summary
Boston Scientific Corporation is recalling 278 units of the Lotus TAVR 27mm Transcatheter Aortic Valve Prosthesis. The recall affects units with material number H749LTV270 and catalog number LTV27. The affected devices were distributed only in Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
The recall was initiated because the Lotus valve may become unlocked during release from the delivery system. If this occurs, it may lead to the percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. In such cases, the first valve could embolize, and it may be necessary to convert the patient to surgery.
The source text does not specify instructions for consumers or patients regarding the recall. The affected serial numbers and expiry dates are listed in the structured product information provided.
The recalled product
- Product
- Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
- 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 (20)
- Serial numbers: 14076030
- 14076031
- 14079012
- 14079013
- 14149023
- 14149031
- 14149038
- 14149040
- 14150028
- 14150029
- 14153080
- 14153081
- 14153082
- 14154040
- 14157024
- 14157025
- 14157026
- 14157027
- 14157029
- 14157030
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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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