Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 098

FDA device recall Z-0187-06 · posted 2005-09-24 · Terminated

Recall details

Recalling firm

Guidant Corporation

Reason for recall

A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include: Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.

Action taken

Important Medical Device Safety Information & Corrective Action , dated 09/22/05 was sent to all affected physicians. This letter explained the failure mode, what devices are affected and gave recommendations. A press release was issued on 09/22/05.

Root cause

Other

Status

Terminated

Product code

DXY

Quantity affected

15,232

Distribution

Nationwide and Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel,

Date initiated

2005-09-22

Date posted

2005-09-24

Date terminated

2006-12-27

Location

Saint Paul, MN