Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT HERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter Recall Number Z-0057-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a “Map: magnetic...Read More
Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S Recall Number Z-0054-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402...Read More
Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S) Recall Number Z-0056-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a...Read More
Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S Recall Number Z-0055-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402...Read More
Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT THERMOCOOL SF NAV Catheters Model Numbers – BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S Recall Number Z-0058-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters....Read More
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