Boston Scientific Corporation: Medical Device Recall in 2019 - (Recall #: Z-1012-2019)

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:

Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220

Product Classification:

Class II

Date Initiated: December 26, 2018

Date Posted: March 20, 2019

Recall Number: Z-1012-2019

Event ID: 82068

Reason for Recall:

The sterile barrier may contain packaging seal defects.

Status: Terminated

Product Quantity: 75 units

Code Information:

Lot 22960202

Distribution Pattern:

The products were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated