Boston Scientific Recalls Flexima Duodenal Bend Biliary Stent Due to Packaging Defects
Boston Scientific is recalling 75 units of Flexima Duodenal Bend Biliary Stents due to potential sterile barrier packaging seal defects.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential packaging seal defects which could compromise sterility, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Boston Scientific Corporation is recalling 75 units of Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220. The recall is being conducted because the sterile barrier may contain packaging seal defects.
The affected products, identified by Lot 22960202, were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were also distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.
Healthcare providers and patients should stop using the affected stents and contact Boston Scientific Corporation for further instructions.
The recalled product
- Product
- Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Biliary Stent
- Affected units
- 75
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 (1)
- Lot 22960202
Distribution
Part of a larger recall action
This product is one of 2 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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