Boston Scientific Recalls Advanix Pancreatic Stents Due to Shelf Life Labeling Error
Boston Scientific is recalling 54 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month duration.
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 source text describes a labeling error regarding shelf life without reporting any illnesses or injuries. This aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Boston Scientific Corporation is recalling 54 units of the Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm (UPN: M00536640). The affected units were manufactured between September 29, 2017, and September 12, 2019, and are identified by lot codes 21973220, 22522254, and 23837823.
The recall was initiated because the product was labeled with a 36-month shelf life rather than the approved 18-month shelf life. This labeling error could lead to the use of the device beyond its validated expiration period.
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. Healthcare providers and facilities should stop using the affected units and contact Boston Scientific for further instructions.
The recalled product
- Product
- Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 54
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 Codes: 21973220 22522254 23837823
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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