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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 11 Results
PMA Number: P020025
 
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FDA Recall
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Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440... 2 08/28/2018 Boston Scientific Corporation
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog ... 2 12/22/2015 Boston Scientific Corp
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog num... 2 12/22/2015 Boston Scientific Corp
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number: M004EPM4790N40; Cata... 2 12/22/2015 Boston Scientific Corp
IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Cata... 2 12/22/2015 Boston Scientific Corp
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve. The BSC Controll... 2 06/16/2014 Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Contr... 2 06/16/2014 Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. The BSC Co... 2 06/16/2014 Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Control... 2 06/16/2014 Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. The BSC Contr... 2 06/16/2014 Boston Scientific Corporation
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