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].

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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	Publish Date
Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication	03/01/2022
Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication	03/01/2022
Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication	03/01/2022
Potential Risk of Strangulation in Children who Use Enteral Feeding Delivery Sets	02/08/2022
Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication	02/04/2022
Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication	01/28/2022
Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems – FDA Safety Communication	01/13/2022
2022 Safety Communications	01/11/2022
Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication	01/11/2022

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	Publish Date
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
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

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	Publish Date
Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of Tip Damage During Use	02/23/2022
BASE10 Genetics Recalls RNAstill MTM Specimen Collection Kits That Are Not Authorized, Cleared, or Approved by the FDA, May Give False Results, and Require Special Training for Safe Handling	02/18/2022
E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results	02/18/2022
Vyaire Medical Recalls bellavista 1000 and 1000e Series Ventilators Due to Issues with Software Configurations	02/17/2022
Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results	01/28/2022
Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam	01/26/2022
Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage During Use	01/21/2022
Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of Harmful Chemical Exposure	01/19/2022
Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval	01/10/2022
Medtronic Recalls Synergy Cranial and StealthStation S7 Cranial Software Due to Potential Risk of Inaccurate Biopsy Depth Gauge Cycle View	01/06/2022
2022 Medical Device Recalls	01/03/2022
Covidien, LP Recalls Puritan Bennett 980 Series Ventilator Due to Manufacturing Assembly Error	01/03/2022
Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks	12/16/2021
Arrow International Inc Recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr, Due to Risk of Separation	12/03/2021

MORE MEDICAL DEVICE RECALLS