Guidant Corporation Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: SR (model 1392). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I AVT pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate ther Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: SR (model 1392). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I AVT pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate ther
Brand
Guidant Corporation
Lot Codes / Batch Numbers
INSIGNIA AVT SSI (model 482) serial no. 100005 - 100324, INSIGNIA AVT VDD (model 882) serial no. 100006 - 100410, INSIGNIA DDD (model 982) serial no. 100007 - 100473, INSIGNIA AVT SR (model 1192) serial no. 100008 - 100473, NEXUS AVT SR (model 1392) serial no. 100016 and 100020, INSIGNIA AVT DR (model 1292) serial no. 100007 - 100798.
Products Sold
INSIGNIA AVT SSI (model 482) serial no. 100005 - 100324; INSIGNIA AVT VDD (model 882) serial no. 100006 - 100410; INSIGNIA DDD (model 982) serial no. 100007 - 100473; INSIGNIA AVT SR (model 1192) serial no. 100008 - 100473; NEXUS AVT SR (model 1392) serial no. 100016 and 100020; INSIGNIA AVT DR (model 1292) serial no. 100007 - 100798.
Guidant Corporation is recalling Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 88 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