Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling
Boston Scientific is recalling 139 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
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, and the hazard is a labeling error regarding shelf life. There are no reported illnesses or injuries, and the risk is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling 139 units of the Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm (UPN: M005336690). The recall involves units manufactured between September 29, 2017, and September 12, 2019, with lot numbers 21568465, 21724128, 22072356, 22250324, 22480145, and 23902872.
The reason for the recall is that these products were labeled with a 36-month shelf life rather than the approved 18-month shelf life. This labeling error could potentially affect the product's performance or safety if used beyond the approved expiration date.
The affected units were distributed nationwide and to foreign countries including Austria, Australia, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Japan, Pakistan, Poland, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, and Turkey. Healthcare providers and facilities should stop using the affected stents and contact Boston Scientific for further instructions.
The recalled product
- Product
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 139
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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