Z-3035-2018Class II

Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X...

Name: Z-3035-2018 Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X...
Creator: SPS Sterilization, Inc
Published: 2018-03-07
License: https://open.fda.gov/license/

SPS Sterilization, Inc / initiated 2018-03-07 / Terminated / root cause: labeling and UDI

FDA source

SPS Sterilization, Inc began a recall of Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized on 2018-03-07. FDA classified it as Class II and gives the reason as "The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3035-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-07
Posted: 2018-09-13
Terminated: 2018-11-27
Recalling firm: SPS Sterilization, Inc
Product: Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
Product code: JCT Prosthesis, Tracheal, Expandable
Reason for recall: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Customers were notified via letter on about 03/02/2018. Instructions included to review inventory for affected devices, arrange for their return to SPS Sterilization, and complete and return the Buisness Response Card. A follow up letter was sent to customer on about 03/07/2018 and included a description of the risk and hazard involved. Instructions remained the same.
Quantity in commerce: 2 units total
Distribution: US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
Product codes and lots: Code Number 40213-R; Lot Number 18030192; Serial Number 21408032017-10, 21408032017-11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3035-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3027-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3028-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3029-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3030-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3031-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3032-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3033-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3034-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3035-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3036-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3037-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3038-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3039-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3040-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13
Z-3041-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13

Product code JCT

K152842Class IIWallstent Rp Endoprosthesis Tracheobronchial, Wallstent Endoprosthesis TracheobronchialBoston Scientific Corporation / cleared 2016-05-19

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)