Guidant Recall | Guidant Insignia and Guidant Nexus

Recall Information on Guidant Insignia and Guidant Nexus Pacemakers

Defective Guidant Devices

Issue

The device can fail, causing intermittent or permanent loss of pacing.

Injuries

Guidant Corp. has identified 52 failures for the subject devices.

Affected Models

Guidant Pacemakers		Guidant Intermedics Pacemakers
Device Family	Model Numbers	Device Family	Model Numbers
Insignia Entra SSI	0484, 0485	NEXUS Entra SSI	1325, 1326
Insignia Entra DDD	0985, 0986	NEXUS Entra DDD	1425, 1426
Insignia Entra SR	1195, 1198	NEXUS Entra SR	1395, 1398
Insignia Entra DR	1294, 1295, 1296	NEXUS Entra DR	1466, 1494, 1495
Insignia Ultra SR	1190	NEXUS Ultra SR	1390
Insignia Ultra DR	1290, 1291	NEXUS Ultra DR	1490, 1491
Insignia Plus SR	1194	NEXUS Plus SR	1394
Insignia Plus DR	1297, 1298	NEXUS Plus DR	1467, 1468
Insignia AVT SSI	482	NEXUS AVT SSI	1328
Insignia AVT VDD	882	NEXUS AVT VDD	1428
Insignia AVT DDD	982	NEXUS AVT DDD	1432
Insignia AVT SR	1192	NEXUS AVT SR	1392
Insignia AVT DR	1292	NEXUS AVT DR	1492

The devices recalled may be specific to certain serial numbers and/or manufactured dates.

Recommendation

Patients with this device should contact their physicians to discuss their options.

Guidant Communications

The following information is provided by Guidant Corporation.