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 DICE@fda.hhs.gov.

---

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
Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA Safety Communication	12/06/2022
Comunicado de seguridad de la FDA: no utilice ciertas almohadillas térmicas eléctricas Mighty Bliss debido al riesgo de lesiones	11/30/2022
Comunicado de seguridad de la FDA: reutilice las cánulas de traqueostomía o cambie a alternativas adecuadas durante su escasez	11/30/2022
Comunicado de seguridad de la FDA: no utilice las almohadas moldeadoras de cabeza para bebés para prevenir o tratar cualquier padecimiento médico	11/30/2022
Se retiran del mercado ciertas mascarillas Philips Respironics para máquinas BiPAP y CPAP debido a un problema de seguridad con imanes que puede afectar a ciertos dispositivos médicos: Comunicado de seguridad de la FDA	11/18/2022
No utilice flotadores para el cuello del bebé debido al riesgo de muerte o lesión: Comunicado de seguridad de la FDA	11/18/2022
No utilice varillas de rayos ultravioleta (UV) que emitan niveles inseguros de radiación: Comunicado de seguridad de la FDA	11/18/2022
Para las pruebas de viruela del mono, utilice muestras de hisopos de lesiones para evitar resultados falsos: Comunicado de seguridad de la FDA	11/18/2022
Actualización: Problemas con las mamografías de Capitol Radiology, LLC, que opera bajo el nombre Laurel Radiology Services en Laurel, Maryland: Comunicado de seguridad de la FDA	11/18/2022
Exactitud y limitaciones de los pulsioxímetros: Comunicado de seguridad de la FDA	11/18/2022
ACTUALIZACIÓN: Uso del Dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicado de seguridad de la FDA	11/18/2022
Algunas máquinas BiPAP de Philips Respironics fueron retiradas del mercado debido a un problema con el plástico: Comunicado de seguridad de la FDA	11/18/2022
Pruebas de antígenos del COVID-19 realizadas en casa - Tome medidas para reducir el riesgo de falsos negativos: Comunicado de seguridad de la FDA	11/18/2022
Implantes de seno: Reportes de carcinoma de células escamosas y varios linfomas en la cápsula alrededor de los implantes: Comunicado de seguridad de la FDA	11/18/2022
Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication	11/03/2022
Reuse Tracheostomy Tubes or Switch to Appropriate Alternatives During Shortage: FDA Safety Communication	10/31/2022
Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication	10/25/2022
Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication	09/08/2022

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
UPDATE: Impella RP System Post-Approval Study Results and Updated Labeling - Letter to Health Care Providers	12/05/2022
Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) Shortage - Letter to Health Care Providers	12/02/2022
Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Due to Shortage - Letter to Health Care Providers	10/31/2022
Update: Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers	09/16/2022
Abbott MitraClip Device: Potential for Clip Lock Malfunctions - Letter to Health Care Providers	09/08/2022

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
Baxter Hillrom Recalls WatchCare Incontinence Management System (IMS) for Risk of RF Interference with Nearby Medical Equipment	11/23/2022
Insulet Recalls Omnipod DASH Insulin Management System's Personal Diabetes Manager (PDM) for Risk of Battery Swelling, Leakage, or Extreme Overheating	11/16/2022
Teleflex Recalls Iso-Gard Filter S for Risk of Splitting or Detaching That May Cause Leakage and Insufficient Air Supply to Patients	11/01/2022
Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices	10/19/2022
Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA	10/12/2022
LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure	09/30/2022
Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern	09/23/2022
Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances	09/15/2022
Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube for Risk of Airway Obstruction	09/12/2022

MORE MEDICAL DEVICE RECALLS