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 2022

Title	Date
Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers	06/02/2022
Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers	05/06/2022
Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers	04/28/2022
Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes – Letter to Health Care Providers	04/27/2022
Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care Providers	04/11/2022
UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes - Letter to Health Care Providers	04/04/2022
Prefilled Saline Flush Syringe Conservation Strategies - Letter to Health Care Personnel	03/21/2022
FDA Advisory Panel Recommendations on Lifelong Surveillance and Long-Term Postmarket Data Collection for Patients with AAA Endovascular Aortic Repair - Letter to Health Care Providers	02/28/2022
UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel	01/19/2022

Letters to Health Care Providers 2021

Title	Date
Getinge’s Maquet/Datascope IABP Devices: Update on Device Failure – Letter to Health Care Providers	12/22/2021
Possible False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR Test Kit Following a COVID-19 Vaccine - Letter to Clinical Laboratory Staff and Health Care Providers	12/17/2021
UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices - Letter to Health Care Providers	12/01/2021
Leadless Pacing Systems: Risk of Major Complications Related to Cardiac Perforation During Implantation - Letter to Health Care Providers	11/17/2021
UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers	10/13/2021
UPDATE: Safe Use of Surgical Staplers and Staples - Letter to Health Care Providers	10/07/2021
Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men - Letter to Health Care Providers	09/27/2021
Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical Laboratory Staff and Health Care Providers	09/17/2021
Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices - Letter to Health Care Providers	09/15/2021
Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng - Letter to Health Care Providers	08/25/2021
Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers	08/18/2021
Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers	07/08/2021
Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities	06/30/2021
Sodium Citrate Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel	06/10/2021
Stop New Implants of the Medtronic HVAD System - Letter to Health Care Providers	06/03/2021
Update: FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities	05/27/2021
Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by HAIOU - Letter to Health Care Providers	05/20/2021
FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities	04/09/2021
Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers	04/01/2021
Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff, and Health Care Providers	03/12/2021
Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers	02/09/2021
Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers	01/08/2021

Letters to Health Care Providers 2020

Title	Date
Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers	12/15/2020
Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers	11/03/2020
Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing - Letter to Health Care Providers	10/07/2020
Potential Risk of Infection during Cardiac Surgery When Using the CardioQuip Modular Cooler-Heater Device – Letter to Health Care Providers	09/30/2020
Conduct a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator (SCS) - Letter to Health Care Providers	09/03/2020
Stop Using Gowns, including Surgical Gowns, from Laws of Motion PPE - Letter to Health Care Providers	08/28/2020
Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Health Care Providers - Letter to Health Care Providers	08/20/2020
Risk of Inaccurate Results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit - Letter to Clinical Laboratory Staff and Health Care Providers	08/17/2020
False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care Providers	07/06/2020
Certain COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers	06/19/2020
Transport Media Safety Risk - Use Compatible Transport Media with SARS-CoV-2 Tests that Use Bleach - Letter to Clinical Laboratory Staff and Health Care Providers	06/04/2020
Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems - Letter to Health Care Providers	05/27/2020
Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization - Letter to Health Care Providers	05/07/2020
Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers	05/07/2020
UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers	04/27/2020
Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers	04/17/2020
Ventilator Supply Mitigation Strategies - Letter to Health Care Providers	03/22/2020
Medical Glove Conservation Strategies - Letter to Health Care Providers	03/20/2020
Surgical Mask and Gown Conservation Strategies - Letter to Healthcare Providers	03/11/2020

Letters to Health Care Providers 2019

Title	Date
Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers	11/19/2019
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
December 2, 2019 UPDATE: Latest Interim post-approval study (PAS) Results Are Available for the Abiomed Impella RP System	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 Providers03/08/2019
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