Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling
Boston Scientific is recalling 271 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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a labeling error regarding shelf life, which is a moderate risk compared to structural defects or active contamination.
Plain-English summary
Boston Scientific Corporation is recalling 271 units of the Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm (UPN: M00536700). The recall affects products manufactured between September 29, 2017, and September 12, 2019.
The recall was initiated because the affected products were labeled with a 36-month shelf life rather than the approved 18-month shelf life. This labeling error may result in the use of expired medical devices.
The affected units were distributed nationwide and in 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. Specific lot numbers are listed in the official recall notice. Healthcare providers and patients should check their inventory and contact Boston Scientific for further instructions.
The recalled product
- Product
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 271
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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