Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: T

FDA device recall Z-2147-2014 · posted 2014-08-05 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

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.

Action taken

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.

Root cause

Software Manufacturing/Software Deployment

Status

Terminated

Product code

LWS

Quantity affected

21

Distribution

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

Date initiated

2014-06-19

Date posted

2014-08-05

Date terminated

2014-12-03

Location

Saint Paul, MN