Z-1567-2016Class II

Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number...

Name: Z-1567-2016 Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number...
Creator: Boston Scientific Corporation
Published: 2016-03-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2016-03-18 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted... on 2016-03-18. FDA classified it as Class II and gives the reason as "Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1567-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-18
Posted: 2016-04-25
Terminated: 2016-08-26
Recalling firm: Boston Scientific Corporation
Product: 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 code: JCT Prosthesis, Tracheal, Expandable
Reason for recall: Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Boston Scientific issued notification letters dated March 17, 2016. The notification instructs the customer 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. Customers with questions should call 866-868-4004. For questions regarding this recall call 508-382-9555.
Quantity in commerce: 4 units
Distribution: Nationwide Distribution to AL, CA, MA, and TX.
Product codes and lots: Lot Number: 18876596 Exp Date: February 1, 201 8

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1567-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1567-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-25

Product code JCT

K141584Class IIUltraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation / cleared 2014-10-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)