Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling
Boston Scientific is recalling 179 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 due to a labeling error regarding shelf life. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate (Score 2).
Plain-English summary
Boston Scientific Corporation is recalling 179 units of the Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm (UPN: M005337206). The recall is due to a labeling error where the products were marked with a 36-month shelf life rather than the approved 18-month shelf life.
The affected products were manufactured between September 29, 2017, and September 12, 2019. The recall covers specific lot numbers: 21615214, 21678783, 22036151, 22423474, 23230411, 23321212, and 24167940. These devices were distributed nationwide and to various 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 check their inventory for these specific lot numbers and stop using the affected devices. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 179
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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