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Boston Scientific CRM Corp

71 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N1 recall (Z-0087-2015)Boston Scientific CRM Corp2014-10-18
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the follow recall (Z-0088-2015)Boston Scientific CRM Corp2014-10-18
Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292 recall (Z-2147-2014)Boston Scientific CRM Corp2014-08-05
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N1 recall (Z-0025-2014)Boston Scientific CRM Corp2013-10-17
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the follow recall (Z-0026-2014)Boston Scientific CRM Corp2013-10-17
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter D recall (Z-1979-2013)Boston Scientific CRM Corp2013-08-16
LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Manageme recall (Z-1339-2013)Boston Scientific CRM Corp2013-05-20
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD recall (Z-0965-2013)Boston Scientific CRM Corp2013-03-18
Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed recall (Z-1445-2012)Boston Scientific CRM Corp2012-04-20
Boston Scientific, LATITUDE Patient Management System Communicator, Models 6476. The LATIT recall (Z-1135-2012)Boston Scientific CRM Corp2012-03-01
LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for recall (Z-1096-2012)Boston Scientific CRM Corp2012-02-23
LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two recall (Z-0333-2012)Boston Scientific CRM Corp2011-12-01
LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integrati recall (Z-0037-2012)Boston Scientific CRM Corp2011-10-12
Boston Scientific, LATITUDE Patient Management System Communicator, Model 6476, Distribute recall (Z-3283-2011)Boston Scientific CRM Corp2011-09-28
LATITUDE Patient Management System Communicator, Model 6482. The LATITUDE Patient Manageme recall (Z-3183-2011)Boston Scientific CRM Corp2011-09-09
Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management Sy recall (Z-2052-2011)Boston Scientific CRM Corp2011-04-26
Guidant, CONTAK RENEWAL 3/3RF Models H170, H175, H177, H179, H210, H215, H217, H219, Guida recall (Z-0016-2011)Boston Scientific CRM Corp2010-10-07
Guidant, Vitality HE ICD, Model: T180DDR, Sterile Lot, Guidant Corporation, Cardiac Rhythm recall (Z-0017-2011)Boston Scientific CRM Corp2010-10-07
Boston Scientific, LATITUDE Communicator, Distributed by Boston Scientific, 4100 Hamline A recall (Z-1631-2010)Boston Scientific CRM Corp2010-05-20
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. Steril recall (Z-1553-2010)Boston Scientific CRM Corp2010-05-08
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N1 recall (Z-1554-2010)Boston Scientific CRM Corp2010-05-08
Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The recall (Z-1555-2010)Boston Scientific CRM Corp2010-05-08
Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H recall (Z-1556-2010)Boston Scientific CRM Corp2010-05-08
VITALITY Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. AVT, mo recall (Z-1557-2010)Boston Scientific CRM Corp2010-05-08
CONTAK RENEWAL 3 (Models H170), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Cardiac R recall (Z-1558-2010)Boston Scientific CRM Corp2010-05-08
VENTAK PRIZM Automatic Implantable Cardioverter Defibrillator (AICD). DR, model 1851, DR H recall (Z-1559-2010)Boston Scientific CRM Corp2010-05-08
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N1 recall (Z-0609-2010)Boston Scientific CRM Corp2010-01-13
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the follow recall (Z-0610-2010)Boston Scientific CRM Corp2010-01-13
Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St recall (Z-0180-2010)Boston Scientific CRM Corp2009-11-12
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N1 recall (Z-1932-2009)Boston Scientific CRM Corp2009-08-18
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. Steril recall (Z-1933-2009)Boston Scientific CRM Corp2009-08-18
Guidant Contak Renewal 3 CRT-D Model H170; 3CRT-D, Model H175; 3HE CRT-D, Model H177; 3HE recall (Z-1620-2009)Boston Scientific CRM Corp2009-07-17
GUIDANT VITALITY DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T17 recall (Z-1621-2009)Boston Scientific CRM Corp2009-07-17
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N1 recall (Z-1678-2009)Boston Scientific CRM Corp2009-07-14
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the follow recall (Z-1679-2009)Boston Scientific CRM Corp2009-07-14
VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872 recall (Z-1513-2008)Boston Scientific CRM Corp2008-08-21
VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-g recall (Z-1514-2008)Boston Scientific CRM Corp2008-08-21
Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. recall (Z-0047-2008)Boston Scientific CRM Corp2007-11-24
Guidant VITALITY AVT, Models A135 and A155. Implantable Cardioverter Defibrillator, ICD. A recall (Z-0048-2008)Boston Scientific CRM Corp2007-11-24
Guidant ASSURE, Model B301, Implantable Cardioverter Defibrillator, ICD. (This model is no recall (Z-0049-2008)Boston Scientific CRM Corp2007-11-24
Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant V recall (Z-0050-2008)Boston Scientific CRM Corp2007-11-24
Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, recall (Z-0051-2008)Boston Scientific CRM Corp2007-11-24
Guidant CONTAK RENEWAL 3 (Models H170, H173, H175), Guidant CONTAK RENEWAL 3 HE (Models H1 recall (Z-0052-2008)Boston Scientific CRM Corp2007-11-24
Guidant CONTAK RENEWAL 3 AVT (Models M150, M155) Guidant CONTAK RENEWAL 3 AVT HE (Models M recall (Z-0053-2008)Boston Scientific CRM Corp2007-11-24
CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynch recall (Z-1047-2007)Boston Scientific CRM Corp2007-07-11
These models are not available in the US. CONTAK RENEWAL 4 (model H190, H195). CONTAK RENE recall (Z-1048-2007)Boston Scientific CRM Corp2007-07-11
CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac recall (Z-1049-2007)Boston Scientific CRM Corp2007-07-11
These models are not available in the US. Guidant CONTAK RENEWAL 4 RF/HE (model H230, H235 recall (Z-1050-2007)Boston Scientific CRM Corp2007-07-11
These models are not available in the US. CONTACT RENEWAL 4 AVT HE (model number M170, M17 recall (Z-1051-2007)Boston Scientific CRM Corp2007-07-11
VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular recall (Z-1052-2007)Boston Scientific CRM Corp2007-07-11
VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), I recall (Z-1053-2007)Boston Scientific CRM Corp2007-07-11
VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Co recall (Z-1054-2007)Boston Scientific CRM Corp2007-07-11
VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylen recall (Z-1055-2007)Boston Scientific CRM Corp2007-07-11
Guidant INSIGNIA I Entra-- family of pacemakers includes the following: SSI (model numbers recall (Z-1293-06)Boston Scientific CRM Corp2006-09-28
Guidant INSIGNIA I Ultra --family of pacemakers includes the following: SR (models1190); a recall (Z-1294-06)Boston Scientific CRM Corp2006-09-28
Guidant INSIGNIA I Plus --family of pacemakers includes the following: SR (models1194); an recall (Z-1295-06)Boston Scientific CRM Corp2006-09-28
Guidant INSIGNIA I AVT --family of pacemakers includes the following: SSI (model 482), VDD recall (Z-1296-06)Boston Scientific CRM Corp2006-09-28
Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantabl recall (Z-1297-06)Boston Scientific CRM Corp2006-09-28
CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK R recall (Z-1298-06)Boston Scientific CRM Corp2006-09-28
VITALITY (models 1870, 1871, T125, T127, T135) and VITALITY 2 (models T165, T167, T175, T1 recall (Z-1299-06)Boston Scientific CRM Corp2006-09-28
Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardi recall (Z-1288-06)Boston Scientific CRM Corp2006-07-27
These models are not available in the US. Guidant CONTAK RENEWAL 4 (models H190, H195). Ca recall (Z-1289-06)Boston Scientific CRM Corp2006-07-27
CONTACT RENEWAL 4 AVT HE model numbers M177. Cardiac Resynchronization Therapy Defibrillat recall (Z-1290-06)Boston Scientific CRM Corp2006-07-27
VITALITY AVT, model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular T recall (Z-1291-06)Boston Scientific CRM Corp2006-07-27
Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135) recall (Z-1292-06)Boston Scientific CRM Corp2006-07-27
VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular Therapies. Sterilized using gaseou recall (Z-1107-05)Boston Scientific CRM Corp2005-08-16
VITALITY AVT, model A135 and A155. Implantable Cardioverter Defibrillator. Atrial and Vent recall (Z-1108-05)Boston Scientific CRM Corp2005-08-16
CONTAK RENEWAL 3 AVT model numbers M150 and M155; CONTAK RENEWAL 3 AVT HE model numbers M1 recall (Z-1109-05)Boston Scientific CRM Corp2005-08-16
VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular Therapies. Sterilized using gaseou recall (Z-0954-05)Boston Scientific CRM Corp2005-06-30
VITALITY AVT, model A135 and model A155. Implantable Cardioverter Defibrillator. Atrial an recall (Z-0955-05)Boston Scientific CRM Corp2005-06-30
CONTACT RENEWAL 3 AVT model numbers M150 and M155; CONTACT RENEWAL 3 AVT HE model numbers recall (Z-0956-05)Boston Scientific CRM Corp2005-06-30

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