The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0916-2015·Announced 2015-01-21

Boston Scientific Recalls Lotus TAVR Valve Prosthesis Due to Unlocking Risk

Boston Scientific is recalling Lotus TAVR 25mm valve prostheses because the valve may unlock during release, potentially requiring additional procedures or surgery.

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: "Lotus valve became unlocked during release from the delivery system. This may lead to 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…"

Plain-English summary

Boston Scientific Corporation is recalling 278 units of the Lotus TAVR 25mm Transcatheter Aortic Valve Prosthesis. The recall involves sterile devices with Material number H749LTV250 and Catalog Number LTV25, which are intended to improve aortic valve function for patients with severe calcific aortic stenosis who are at extreme or high risk for standard surgical valve replacement.

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 open surgery.

The affected units were distributed only in Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland. The recall covers specific serial numbers with expiry dates ranging from November 15, 2014, to January 24, 2015. Healthcare providers and patients should contact Boston Scientific for further instructions on managing the affected devices.

The recalled product

Product
Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV250, Catalog Number LTV25; 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
Hazard
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: 14126051
  • 14126052
  • 14126053
  • 14127058
  • 14128047
  • 14128048
  • 14128049
  • 14128050
  • 14129004
  • 14129005
  • 14129006
  • 14129007
  • 14129008
  • 14133006
  • 14133007
  • 14133008
  • 14133009
  • 14133010
  • 14134042
  • 14134043

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.

See all 3 products in this recall →

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