Boston Scientific Corporation: Medical Device Recall in 2016 - (Recall #: Z-1567-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths

Product Classification:

Class II

Date Initiated: March 18, 2016

Date Posted: May 4, 2016

Recall Number: Z-1567-2016

Event ID: 73660

Reason for Recall:

Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm

Status: Terminated

Product Quantity: 4 units

Code Information:

Lot Number: 18876596 Exp Date: February 1, 201 8

Distribution Pattern:

Nationwide Distribution to AL, CA, MA, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated