Boston Scientific Pancreatic Stent Recalled for Incorrect Shelf Life Labeling
Boston Scientific is recalling 35 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, but the source text identifies the issue as a labeling error regarding shelf life without reporting any illnesses, injuries, or deaths. This aligns with the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Boston Scientific Corporation is recalling 35 units of the Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm (UPN: M00536730). The affected units were manufactured between September 29, 2017, and September 12, 2019. 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 lot numbers are 21542436, 21897084, and 23230412. The products 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.
This is a Class II recall. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Consumers are advised to contact their healthcare provider if they have received this device.
The recalled product
- Product
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 35
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 Numbers: 21542436 21897084 23230412
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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