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.
What this means for you
Illness, injury, or structural failure has been reported. 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 ao
- 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCoaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12