Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling
Boston Scientific is recalling 66 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
What this means for you
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 involves a situation that could temporarily cause or present a minor threat to health. The hazard is a labeling error regarding shelf life, which is a moderate risk compared to direct contamination or structural failure.
Plain-English summary
Boston Scientific Corporation is recalling 66 units of the Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm (UPN: M00536620). The recall involves specific lot numbers: 21776487, 22136470, 22896244, and 23902871. These products were 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 the device beyond its approved expiration date.
The recalled 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. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 66
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: 21776487 22136470 22896244 23902871
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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