Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibr

FDA device recall Z-0826-06 · posted 2006-05-02 · Terminated

Recall details

Recalling firm

Guidant Corporation

Reason for recall

77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications.

Action taken

Guidant Sales Representatives are retrieving non-implanted devices April 10-12, 2006. If a device is implanted the physician is sent an Urgent Medical Device Safety Information & Corrective Action letter, April 11-14, 2006. This letter describes the issue, states that Guidant is retrieving all non-implanted devices and that Guidant is currently conducting tests on retrieved devices. Physicians will be advised once more information is available.

Root cause

Other

Status

Terminated

Product code

NIK

Quantity affected

20 devices

Distribution

Nationwide. AZ, FL, GA, IL, IN, KY, MA, ME, MI, MN, NC, NE, NY, OH, PA, TN, TX, UT, VA, WI. OUS to include: Australia, Canada, Germany, Italy, Netherlands, Portugal, Slovenia, Spain.

Date initiated

2006-04-07

Date posted

2006-05-02

Date terminated

2007-04-01

Location

Saint Paul, MN