Boston Scientific Corporation: Medical Device Recall in 2019 - (Recall #: Z-0549-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 21, 2019

Date Posted: December 4, 2019

Recall Number: Z-0549-2020

Event ID: 84150

Reason for Recall:

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

Status: Terminated

Product Quantity: 66 units

Code Information:

Lot Numbers: 21776487 22136470 22896244 23902871

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated