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Medical Device Safety

The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. The lists below contain our most recent information. Other safety communications can be found using the links on the left side of this page. For additional information, contact us at: 1-800-638-2041 or [email protected].

Recent Medical Device Safety Communications

The FDA's analyses and recommendations for patients and health care providers about ongoing medical device safety issues.

FDA Safety Communication Date
Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety Communication 03/31/21
Mammography Problems at Tennessee Women’s Care P.C. in Nashville, TN: FDA Safety Communication 03/30/21
Risk of Device Component Breaking in Patients with Stryker’s STAR Ankle: FDA Safety Communication 03/15/21
Improper Use of Thermal Imaging Devices: FDA Safety Communication 03/04/21
Pulse Oximeter Accuracy and Limitations: FDA Safety Communication 02/19/21
Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication 01/04/21
Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication 12/29/20
Wear Face Masks with No Metal During MRI Exams: FDA Safety Communication 12/07/20
UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication 12/04/20
Mammography Problems at Allison Breast Center at Monument Radiology in Richmond, Virginia: FDA Safety Communication 09/25/20
Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication 09/24/20
FDA Reminds Users about the Importance of Following Instructions for the Cold-Therapy Mode of Water-Circulating Hot/Cold Therapy Devices: FDA Safety Communication 09/09/20
Risk of loss of coordination during water-related activities in Parkinson’s Patients with Deep Brain Stimulators: FDA Safety Communication 07/30/20
FDA Reminds Owners and Operators About Repair and Maintenance of Tanning Beds and Booths: FDA Safety Communication 07/22/20
SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices: FDA Safety Communication 03/03/20

MORE MEDICAL DEVICE SAFETY COMMUNICATIONS

Recent Letters to Health Care Providers

Information for health care providers about the safe use of medical devices in medical facilities.

Device Name Date
FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities 04/09/21
Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers 04/01/21
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  03/12/21
Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers 02/09/21
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 01/08/21
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 12/15/20
Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers 11/03/20
Potential Risk of Infection during Cardiac Surgery When Using the CardioQuip Modular Cooler-Heater Device - Letter to Health Care Providers 09/30/20
Conduct a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator (SCS) - Letter to Health Care Providers 09/03/20
Stop Using Gowns, including Surgical Gowns, from Laws of Motion PPE - Letter to Health Care Providers 08/28/20
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 08/20/20
Risk of Inaccurate Results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit - Letter to Clinical Laboratory Staff and Health Care Providers 08/17/20
False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care Providers 07/06/20
Certain COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers 06/19/20
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 06/04/20

MORE LETTERS TO HEALTH CARE PROVIDERS

Recent Medical Device Recalls

Medical device recalls that may potentially present significant risks to consumers or users of the product.

Device Name Date
Abbott (formally known as “St. Jude Medical”) Recalls Assurity™ and Endurity™ Pacemakers for Potential Moisture Ingress Causing Electrical Short and Reduced Battery Life 05/13/21
Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues 05/12/21
Pacific Medical Group (DBA Avante Health Solutions) Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts 04/30/21
Cordis Recalls Precise PRO Rx US Carotid System Due to Risk of Separation in Device During Use 04/23/21
Medtronic Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping Console for Possible Electrical Failure Causing the Pump to Stop 04/20/21
Tenacore Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly Due to Possible Cracked or Separated Bezel Repair Posts 04/19/21
CareFusion 303, Inc. Recalls BD Alaris Pump Module Model 8100 Due to Risk of Stuck or Unresponsive Keys 04/16/21
Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports 04/15/21
Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum 04/12/21
Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Due to Risk of Shortened Battery Life 04/12/21
Medtronic Recalls Valiant Navion Thoracic Stent Graft System Due to Risk of Stent Fractures and Type III Endoleaks 04//09/21
ACIST Recalls Kodama Intravascular Ultrasound Catheter Due to Risk of Broken O-Ring Pieces Flushing into Arteries During Use 03/17/21
Combat Medical Systems, LLC, Recalls Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood Transfusion Set, Fresh Whole Blood Donor Set for Possible Broken or Bent Needles 03/12/21
Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped 03/01/21
Hillrom Recalls Liko Multirall 200 Overhead Lift Due to Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link 1 Strap Lock) to S65 Hook 02/22/21
Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit 02/19/21
Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures 02/02/21

MORE MEDICAL DEVICE RECALLS



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