These models are not available in the US. Guidant CONTAK RENEWAL 4 RF/HE (model H230, H235) Guidant CONTAK RENEWAL 4 RF

FDA device recall Z-1050-2007 · posted 2007-07-11 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

Reason for recall

Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months.

Action taken

An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.

Root cause

Other

Status

Terminated

Product code

NIK

Quantity affected

1,217

Distribution

Worldwide, including USA, Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Czechoslovakia, Denmark, Dominican Republic, Ecua

Date initiated

2007-03-23

Date posted

2007-07-11

Date terminated

2008-03-02

Location

Saint Paul, MN