FDA-Device2019-12-04Class II
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690
Hazard
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
Sold states
Nationwide Foreign: Austria Australia Belgium Bulgaria Croatia Czech Rep Denmark Finland France Germany Great Britain Italy Japan Pakistan Poland Russian Fed. Slovakia South Africa Spain Sweden Switzerland Thailand Turkey
Affected count
139 units
Manufactured in
300 Boston Scientific Way, Marlborough, MA, United States
Products
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm UPN: M005336690
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0556-2020More Boston Scientific Corporation recalls
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- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for sterile pouch breach risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile packaging breach
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