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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 22 Results
PMA Number: P890003
 
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Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber atrial sensing, ventricular sensing and pacing... 1 06/11/2009 Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software compo... 2 07/23/2025 Medtronic, Inc.
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software compone... 2 07/23/2025 Medtronic, Inc.
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with t... 2 07/17/2025 Medtronic, Inc.
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the foll... 2 07/17/2025 Medtronic, Inc.
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2... 2 09/13/2024 Medtronic Inc.
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devi... 2 04/30/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P... 2 04/30/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CareLink SmartSync Device Manager, Model Number 24970A 2 07/10/2020 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Patient Connector, Model Number 24967 2 07/10/2020 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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