Boston Scientific Pancreatic Stent Recall Due to Incorrect Shelf Life Labeling
Boston Scientific is recalling Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month period.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error regarding shelf life, which is a moderate risk compared to active contamination or structural failure.
Plain-English summary
Boston Scientific Corporation is recalling 542 units of the Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm (UPN: M00536630). The recall involves units manufactured between September 29, 2017, and September 12, 2019.
The reason for the recall is that the affected products were labeled with a 36-month shelf life rather than the approved 18-month shelf life. This labeling error could lead to the use of expired medical devices, which may not perform as intended.
The products were distributed nationwide and to several 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 lots and contact Boston Scientific for instructions on return or replacement.
The recalled product
- Product
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 542
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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