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Medical Device Safety

Update – November 21, 2024

CDRH is announcing a communications pilot to enhance the medical device recall program and to improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls. The pilot will include early alerts of potentially high-risk device removals or corrections related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology. This pilot follows the commitments noted in our 2024 Safety Report and recommendations from the Patient Engagement Advisory Committee, to enhance our medical device recall program.

The FDA monitors reports of adverse events and other problems with medical devices and when needed, alerts patients, health care providers, industry, and the public. The lists below contain our most recent information. For additional information, contact us – Division of Industry and Consumer Education (DICE).

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
La FDA alerta a los pacientes para que revisen con frecuencia las configuraciones de alerta de los teléfonos inteligentes relacionados con la diabetes, en especial, después de realizar cambios en el hardware o el software del teléfono: FDA Safety Communication
Inaalertuhan ng FDA ang mga Pasyente na Regular na Suriin ang mga Setting ng Alerto sa Kanilang Smartphone Device na may Kaugnayan sa Diabetes, Lalo na Pagkatapos ng mga Pagbabago sa Hardware o Software ng Telepono: FDA Safety Communication
FDA 提醒患者定期检查糖尿病相关智能手机器械警报设置，特别是在手机硬件或软件发生变更后：美国食品药品监督管理局 (FDA) 安全通报
Ang mga Accolade Pacemaker Device ng Boston Scientific at Potensiyal na Pangangailangan sa Maagang Pagpapalit ng Device – Pangkaligtasang Komunikasyon ng FDA
Los marcapasos Accolade de Boston Scientific y la posible necesidad de reemplazarlos antes de tiempo: Comunicado de seguridad de la FDA
波士顿科学公司所生产的 Accolade 起搏器器械可能需要提早更换——FDA 安全通报
FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes: FDA Safety Communication
Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication
Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication

MORE MEDICAL DEVICE SAFETY COMMUNICATIONS

Recent Medical Device Recalls and Early Alerts

Medical device recalls that may potentially present significant risks. Note that Early Alerts, as part of a pilot, include information on actions being taken by companies that the FDA believes are likely to be the most serious type of recall, but where the FDA may not yet have determined that the actions meet the regulatory definition of a recall. These actions may include when companies remove products from the market, correct products, or update instructions for using products due to potentially high safety risks.

Device Name Publish Date
Early Alert: Infusion Pump Issue from Baxter Healthcare Corporation
Endovascular System Recall: Philips Removes and Discontinues Distribution of Tack Endovascular System Due to User Challenges That Caused Additional Procedures to Reposition or Remove Implant
Vaporizer Recall: Getinge Removes Vaporizer Sevoflurane Quick-Fil and Expands Recall of Vaporizer Sevoflurane Maquet Filling due to Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride
Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due to High Rate of Stroke or Transient Ischemic Attack
Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from Incorrectly Positioned Mattresses
Power Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+ Power Assist Device Due to Risk for Motor to Be Unresponsive to the User
Regard Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due to a Recalled Component, the Neo-Tee T-Piece Resuscitator With An Undersized Controller Spring
Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures
Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to a Manufacturing Issue That May Lead to Early Device Replacement
Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal
Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing Circuits due to Venturi Component Malfunctions that May Reduce Pressure and Volume Flow
Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub that May Detach
Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular
Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire
Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable
Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks
Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective Ventilation
Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient Results
Update on Alert: Infusion Pump Software Issue from Fresenius Kabi USA
Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use
Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient Care
Update on Alert: Solution Set Issue from Baxter Healthcare Corporation
Update on Alert: Fluid Delivery Set Issue from Medline
Update on Alert: Extracorporeal Blood Circuit Issue from Nuwellis
Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus

MORE MEDICAL DEVICE RECALLS AND EARLY ALERTS

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