Z-2147-2014Class II

Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO

Name: Z-2147-2014 Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO
Creator: Boston Scientific CRM Corp
Published: 2014-06-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2014-06-19 / Terminated / root cause: software

FDA source

Boston Scientific CRM Corp began a recall of Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide... on 2014-06-19. FDA classified it as Class II and gives the reason as "A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2147-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-19
Posted: 2014-08-05
Terminated: 2014-12-03
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Sales representatives hand delivered a Boston Scientific "Medical Device Retrieval" Letter dated June 19, 2014 or June 20, 2014 when they were retrieving the devices from the hospital shelves. The letter was addressed to Hospital Administrator. The letter described the problem, product being recalled and the retrieval of the device by Boston scientific sales representative. For further questions they can contact their local sales representative or Boston Scientific International Technical Services. Physicians were contacted via telephone starting on July 6, 2014. A Boston Scientific letter dated July 8, 2014 followed the telephone conversation. For further information physicians can contact their local Boston Scientific representative or Technical Services at 1-800-227-3422.
Quantity in commerce: 21
Distribution: Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France
Product codes and lots: Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2147-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2147-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-04

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)