Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and DR (models1297, 1298). Interme

FDA device recall Z-0193-06 · posted 2005-11-23 · Terminated

Recall details

Recalling firm

Guidant Corporation

Reason for recall

Another failure mode, which occurs at a low rate, has been identified with 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. UPDATE: Guidant is issuing an Advisory Update to physicians in December 2005. This update provides information relative to the failure mode including the identified cause; FDA's classification; Guidant representatives will retrieve and replace any hospital inventory with product free from "Mode 2" peri-implant failure; and recommended actions.

Root cause

Other

Status

Terminated

Product code

DXY

Quantity affected

174,848

Distribution

Nationwide and Arab Emerites, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Ge

Date initiated

2005-09-22

Date posted

2005-11-23

Date terminated

2007-01-05

Location

Saint Paul, MN