Guidant Corporation Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and
Brand
Guidant Corporation
Lot Codes / Batch Numbers
INSIGNIA Ultra SR (model 1190) serial no. 889963 - 891468, (model 1291) serial no. 100279 - 100913, NEXUS Ultra DR (model 1490) serial no. 100007, 100008, 100009, 100013, 100014, 100015, 100016, 100017, 100018, (model 1491) serial no. 100007, 100008, 100009, 100010, 100013, 100015, 100016, 100017, 100018.
Products Sold
INSIGNIA Ultra SR (model 1190) serial no. 889963 - 891468; NEXUS Ultra SR (model 1390) serial no. 100007 - 100034. INSIGNIA Ultra DR (model 1290) serial no. 100678 - 105229; (model 1291) serial no. 100279 - 100913; NEXUS Ultra DR (model 1490) serial no. 100007, 100008, 100009, 100013, 100014, 100015, 100016, 100017, 100018; (model 1491) serial no. 100007, 100008, 100009, 100010, 100013, 100015, 100016, 100017, 100018.
Guidant Corporation is recalling Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (mo due to A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026