Boston Scientific Recalls Lotus TAVR 23mm Transcatheter Aortic Valve Prosthesis
Boston Scientific is recalling 278 units of the Lotus TAVR 23mm 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 is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Boston Scientific Corporation is recalling 278 units of the Lotus TAVR 23mm Transcatheter Aortic Valve Prosthesis. The affected devices are sterile and were distributed in Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland between November 15, 2014, and January 24, 2015.
The recall is due to a defect where the Lotus valve may become unlocked during release from the delivery system. This malfunction can lead to the percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize, and it may be necessary to convert the patient to surgery.
The source text does not specify specific actions for consumers or patients, nor does it report any specific injuries or illnesses associated with this defect. The recall is classified as Class I by the FDA.
The recalled product
- Product
- Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; 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: 14113043
- 14118011
- 14118012
- 14119047
- 14119048
- 14119049
- 14119050
- 14119051
- 14120027
- 14120028
- 14120029
- 14120030
- 14120031
- 14121035
- 14121036
- 14121037
- 14121038
- 14121039
- 14121040
- 14121041
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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