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U.S. Department of Health and Human Services

Medical Device Recalls

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5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). P... 1 Dec-08-2016 SynCardia Systems Inc.
Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indi... 1 Dec-02-2016 Centurion Medical Products Corporation
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T... 1 Nov-29-2016 Greatbatch Medical
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the card... 1 Nov-09-2016 SentreHeart Inc
X-Celerator Hydrophilic Exchange Guidewire 1 Nov-09-2016 Micro Therapeutics Inc, Dba Ev3 Neurovascular
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: Th... 1 Nov-09-2016 Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatm... 1 Nov-09-2016 Micro Therapeutics Inc, Dba Ev3 Neurovascular
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature fo... 1 Nov-09-2016 Micro Therapeutics Inc, Dba Ev3 Neurovascular
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No.... 1 Oct-21-2016 St Jude Medical Inc.
Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assur... 1 Oct-21-2016 St Jude Medical Inc.

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