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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1299-06 - VITALITY (models 1870, 1871, T125, T127, T135) and VITALITY 2 (models T165, T167, T175, T177). Implantable Cardioverter Defibrillators (ICD). Quantities Distributed by model are as follows: VITALITY...
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2
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09/28/2006
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Boston Scientific CRM Corp
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Z-1297-06 - Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation...
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2
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09/28/2006
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Boston Scientific CRM Corp
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Z-1294-06 - 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 139...
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2
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09/28/2006
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Boston Scientific CRM Corp
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Z-1295-06 - Guidant INSIGNIA I Plus --family of pacemakers includes the following: SR (models1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: DR (model 1467,...
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2
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09/28/2006
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Boston Scientific CRM Corp
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Z-1293-06 - Guidant INSIGNIA I Entra-- family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). --Intermedi...
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2
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09/28/2006
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Boston Scientific CRM Corp
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Z-1296-06 - 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 pacemaker...
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2
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09/28/2006
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Boston Scientific CRM Corp
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Z-1298-06 - CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK RENEWAL TR2 devices are not available in the US. Quantities Distributed by model are as follows: CONTAK RENE...
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2
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09/28/2006
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Boston Scientific CRM Corp
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