Boston Scientific Corporation Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Lot Numbers: 21776487 22136470 22896244 23902871
Products Sold
Lot Numbers: 21776487 22136470 22896244 23902871
Boston Scientific Corporation is recalling Boston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Boston Scientific issued Notifications to consignees via Federal Express Priority mail on October 21, 2019. The notification instructs the account to check their inventory remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026