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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Boston Scientific Corporation: Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life

Agency Publication Date: November 25, 2019
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Affected Products

Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610

Lot Numbers: 21312746 21776485 22737577 23257631 24271827

Lot Numbers:
Numbers
Product: Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620

Lot Numbers: 21776487 22136470 22896244 23902871

Lot Numbers:
Numbers
Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630

Lot Numbers: 21483840 21512594 21724125 21833851 22007180 22195528 22212528 22647190 22828072 23000367 23257632 23578453 23615959 23796006 24167478 24229865 24396823

Lot Numbers:
Numbers
Product: Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640

Lot Codes: 21973220 22522254 23837823

Lot Numbers:
Codes
Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650

Lot Numbers: 21187998 21285271 21337147 21483841 21512595 21662812 21724126 21833852 21922988 22036149 22136471 22307745 22359735 22613955 22700891 23035017 23295961 23492660 23541961 24006978 24271828 24383293 24411526

Lot Numbers:
Numbers
Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660

Lot Numbers: 21312747 21865108 22275742 24411527

Lot Numbers:
Numbers
Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm UPN: M00536670

Lot Numbers: 21376782 21636753 21724127 21833853 22007181 22136472 22195529 22212529 22522255 22613956 22858807 23073638 23321211 23408729 23875252 24167479 24229866 24411528

Lot Numbers:
Numbers
Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680

Lot Numbers: 21285272 21568464 21750673 21865109 22072355 22613957 23408730 23492662

Lot Numbers:
Numbers
Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690

Lot Numbers: 21568465 21724128 22072356 22250324 22480145 23902872

Lot Numbers:
Numbers
Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700

Lot Numbers: 21483842 21512596 21724129 21806787 21973221 22307744 22460195 23073639 23492663 24271829

Lot Numbers:
Numbers
Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm UPN: M00536710

Lot Numbers: 21750674 22036150 22647191 23902873

Lot Numbers:
Numbers
Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm UPN: M005337206

Lot Numbers: 21615214 21678783 22036151 22423474 23230411 23321212 24167940

Lot Numbers:
Numbers
Product: Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730

Lot Numbers: 21542436 21897084 23230412

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84150
Status: Resolved
Manufacturer: Boston Scientific Corporation
Manufactured In: United States
Units Affected: 13 products (109 units; 66 units; 542 units; 54 units; 940 units; 97 units; 651 units; 222 units; 139 units; 271 units; 66 units; 179 units; 35 units)
Agency Last Updated: January 22, 2020

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.