EndoVive Replacement Button Kits mislabeled with incorrect sizing
Boston Scientific is recalling EndoVive Replacement Button Kits due to sizing mislabeling that could cause undersizing and serious complications including tissue damage and sepsis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. However, the mislabeling creates significant risk of serious harm, including tissue damage, necrosis, infection, and sepsis. Per the severity rubric, risk-of-harm products with no reported injury are capped at High (3).
Plain-English summary
Boston Scientific Corporation is recalling certain EndoVive Replacement Button Kits with ENFIT 28F 2.8 CM due to a labeling error. The affected kits contain Stoma Measuring Devices that are sized for 18/24F replacement buttons but are labeled as 28F.
This mislabeling could lead to undersizing the replacement button. Undersized buttons can embed into the gastric wall, causing erosion, tissue necrosis, infection, sepsis, and related complications.
The affected products were distributed internationally to Japan only, with 74 units distributed. The recalled items include UPN M00509500 (Lot 31073152) and UPN M00509510 (Lots 31221751, 31761882, 32409573).
Healthcare providers and patients should contact Boston Scientific if they have any of the recalled products.
The recalled product
- Product
- EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
- Manufacturer
- Boston Scientific Corporation
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 (8)
- UPN M00509500
- GTIN (UDI-DI) 08714729902713
- Lot 31073152
- UPN M00509510
- GTIN (UDI-DI) 08714729902720
- Lots 31221751
- 31761882
- 32409573.
Distribution
Distribution scope not specified by the agency.
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