Boston Scientific CRM Corp: Medical Device Recall in 2014 - (Recall #: Z-2147-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 19, 2014

Date Posted: August 13, 2014

Recall Number: Z-2147-2014

Event ID: 68700

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.

Status: Terminated

Product Quantity: 21

Code Information:

Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339.

Distribution Pattern:

Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France

Voluntary or Mandated:

Voluntary: Firm initiated