Advanced Bionics Precision Linear Leads 의 리콜

Recall

36624

Class 2

Z-0299-2007

2006-09-21

2007-01-10

Terminated

United States

2012-01-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49022

A small number of unimplanted precision linear leads may have been assembled with incorrect electrode material. at high stimulation levels, the metal may corrode and dissolved metals may enter the patient.

In United States, the clinician recall notification letters were distributed by Fed-Ex or U.S. Postal Service certified mail on 09/21/2006. For the other regions, the in-country representatives started providing notification to the clinicians on 09/21/2006. The recall notification letters will instruct physicians to immediately return the unimplanted units.