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  1. Medical Device Safety

Letters to Health Care Providers

The FDA posts the letters it sends to health care providers about safety concerns with medical devices used in health care facilities.

Letters to Health Care Providers 2019

Title Date
August 7, 2019 UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality 08/07/2019
Programmable CSF Shunts and Magnetic Field Interference with Implanted Hearing Devices - Letter to Health Care Providers 07/16/2019
UPDATE On Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors - Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures 05/23/2019
UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers 05/21/2019
UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers 03/15/2019
Safe Use of Surgical Staplers and Staples - Letter to Health Care Providers 03/08/2019
Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) - Letter to Health Care Providers 02/06/2019
Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers 02/04/2019
Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers 01/17/2019

 

Letters to Health Care Providers 2018

Title Date
Update Regarding Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry 11/08/2018
Update Regarding Unintended Heating Associated with the Monteris Medical NeuroBlate Probe 11/08/2018
Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers 11/01/2018
The FDA Encourages Use of Enteral Device Connectors that Reduce Risk of Misconnection and Patient Injury - Letter to Health Care Providers 09/07/2018
SynCardia Systems - TAH-t Companion 2 Driver System (C2) and Risk of Mortality and Stroke - Letter to Health Care Providers 08/17/2018
Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers 08/08/2018
UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems - Letter to Health Care Providers 06/19/2018
UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers 06/04/2018
Neurovascular Stents Used for Stent-Assisted Coiling of Unruptured Brain Aneurysms: Letter to Health Care Providers 05/08/2018
Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry: Letter to Health Care Providers 04/24/2018
Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors - Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures 04/18/2018
Unintended Heating Associated with the Monteris Medical NeuroBlate Probe: Letter to Health Care Providers 03/22/2018
Neurovascular Embolization Coils and the Potential for Increased Image Artifact When Using Magnetic Resonance Angiography for Follow-Up - Letter to Health Care Providers 03/12/2018
Death and Pulmonary Embolism Related to Extracorporeal Photopheresis (ECP) Treatment - Letter to Health Care Providers 02/05/2018
Feeding Tube Placement Systems - Letter to Health Care Providers 01/11/201

 

Letters to Health Care Providers 2017

Title Date
UPDATE on Increased Rate of Major Adverse Cardiac Events Observed in Patients Receiving Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) - Letter to Health Care Providers 10/31/2017
Type III Endoleaks Associated with Endovascular Graft Systems - Letter to Health Care Providers 09/28/2017
UPDATE on SynCardia Systems - TAH-t Companion 2 Driver System (C2) and Freedom Driver System - Letter to Health Care Providers 09/25/2017
Information about the Use of Forced Air Thermal Regulating Systems - Letter to Health Care Providers 08/30/2017
UPDATE: Potential risks with liquid-filled intragastric balloons -- Letter to Health Care Providers 08/10/2017
UPDATE: Severe Bleeding and Hematomas Associated with VASCU-GUARD Peripheral Vascular Patch – Letter to Health Care Providers 07/06/2017
The Use of Non-Medtronic Devices with Medtronic’s NavLock Tracker– Letter to Health Care Providers 05/02/2017
Neurovascular Thrombus Retrieval Catheters and Guide Catheters Used During Neurological Interventional Procedures: Differences in FDA Review and Intended Use - Letter to Health Care Providers 03/01/2017

 

Letters to Health Care Providers 2016

Title Date
Potential Problems with Battery-Powered Mobile Medical Carts in Health Care Facilities that May Result in Fire: Letter to Health Care Professionals 12/27/2016
Discontinue Use of Multidata Systems International Corp. Radiation Therapy Devices - Letter to Health Care Providers 10/20/2016
Warning about magnetic interference between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators (ICDs) or pacemakers – Letter to Health Care Providers 03/08/2016