TL;DR: The FDA posted an Early Alert on October 15, 2026 for Edwards Lifesciences Commander M delivery systems after three balloon-burst reports, one death and one serious injury.
Newest verified action on the FDA list
According to Medical Device Recalls and Early Alerts | FDA, the table entry dated 10/15/2026 identifies an Early Alert for Transcatheter Mitral Valve Delivery System Issue from Edwards Lifesciences with status Early Alert – FDA collecting information.
According to Early Alert: Transcatheter Mitral Valve Delivery System Issue from Edwards Lifesciences | FDA, CDRH is issuing the Early Alert to notify the public of a potentially high-risk device issue and will update the web page as significant new information becomes available.
The affected products are Commander M delivery systems for SAPIEN M3 Transcatheter Mitral Valve Replacement System in lots 67718561, 67804014, 67887043, and 67887044.
The FDA page states that Edwards Lifesciences issued a letter to affected customers recommending certain delivery systems used for SAPIEN M3 transcatheter mitral valve replacement be removed from where they are used or sold.
The instruction on the page is do not use the identified affected products listed above.
The page states that units with other lot numbers are not impacted by this recall and can continue to be used.
The page states that on October 5, Edwards Lifesciences sent all affected customers a letter recommending sharing the notice with appropriate clinical staff at the site.
The same October 5 letter recommends searching inventory for and removing the affected product.
The same October 5 letter recommends working with an Edwards Representative to return any impacted product to Edwards.
The page instructs readers to check the web page for updates while FDA reviews information about the potentially high-risk device issue.
Why FDA flagged the Commander M system
Edwards Lifesciences stated it has received three reports of balloons bursting during inflation.
Potential injuries associated with balloon burst include embolism and inability to retrieve the device through the guide sheath.
The page states that inability to retrieve the device may require additional intervention, including surgery.
The page states that because this patient population is deemed unsuitable for surgery, these interventions carry a high risk of serious adverse health consequences including death.
As of October 5, Edwards Lifesciences has reported one death and one serious injury associated with this issue.
The Commander M delivery systems are used to deliver a replacement mitral heart valve to a patient’s heart through blood vessels, without requiring open chest surgery.
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Edwards Lifesciences at 1-800-424-3278 or [email protected].
Health care professionals and consumers may report adverse reactions or quality problems experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
The contact number listed for MedWatch reporting is 1-888-INFO-FDA (1-888-463-6332).
Philips Lumify ultrasound Early Alert of October 9, 2026
According to Early Alert: Diagnostic Ultrasound System Issue from Philips, the entry is titled Early Alert: Diagnostic Ultrasound System Issue from Philips Ultrasound and was sent at 10/09/2026 11:46 AM EDT.
The bulletin states that FDA is aware that Philips Ultrasound has issued a letter to affected customers recommending all Lumify diagnostic ultrasound systems have updated use instructions.
Philips Ultrasound stated that due to a software issue, the Lumify Android or iOS application used with its ultrasound transducers may not recognize a previously registered transducer.
The bulletin states the application will prompt users for re-registration without warning prior to point-of-care use.
Scanning functionality is prevented until the registration step has been completed.
Registration requires Wi-Fi or cellular signal access.
Lumify devices used outside the hospital, such as in ambulances, aircraft, or field settings, are at greater risk due to more limited access to Wi-Fi/cellular signals.
Philips has received reports that the unexpected re-registration events have prevented scanning in pre-hospital environments and delayed care to patients.
These pre-hospital events occurred outside of Wi-Fi or cellular access.
Additionally, Philips reported that the connection between the Lumify transducer USB cable to a customer’s tablet or phone may disconnect or have an unstable connection during use.
The bulletin states that unstable connection may disrupt continuous function of the device and result in a delay of care.
Loss of functionality or system failure during a procedure may result in a delay in diagnosis and/or treatment.
The bulletin states that because the Lumify system is intended for point-of-care use, where ultrasound imaging supports rapid diagnosis and treatment, real-time decision-making, triage of unstable patients, and access to diagnostic capabilities in mobile, underserved, or remote settings, loss of functionality or system failure may have greater consequences than with traditional ultrasound devices.
The bulletin states that depending on the clinical situation and patient condition, delays in diagnosis or treatment could lead to serious injury or death.
As of September 29, 2026, Philips Ultrasound has reported eight serious injuries and four deaths associated with this issue.
Customers in the U.S. with questions about this recall should contact Philips Ultrasound Customer Care Solutions Center at (800) 722-9377.
Confirmed recalls posted September-October 2026
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 10/02/2026 identifies Breathing Circuit Recall: Draeger Removes VentStar Resus Neo Hoses with status Recall Confirmed.
According to MedSun Newsletter, October 2026, the highlighted entry lists Draeger Removes VentStar Resus Neo Hoses 10/2/26.
According to Medical Device Recalls, Draeger, Inc. initiated a Class I recall for VentStar Resus Neo breathing circuits Part MP00310 on September 3, 2026, due to potential hose cracks that can cause leaks or disconnection.
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/24/2026 identifies Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers with status Recall Confirmed.
According to MedSun Newsletter, October 2026, the highlighted entry lists Abiomed Removes Automated Impella Controllers 9/24/26.
According to Medical Device Recalls, Abiomed, Inc. initiated a Class I recall for various Automated Impella Controllers including models 0042-0000-US, 0042-0010-US, and 0042-0040-US on September 16, 2026, to address purge retainer failures that could lead to loss of hemodynamic support.
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/03/2026 identifies Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Leads with status Recall Confirmed.
According to MedSun Newsletter, October 2026, the highlighted entry lists Boston Scientific Removes Infinion CX Leads 9/3/26.
According to Medical Device Recalls, Boston Scientific Corporation initiated a Class I recall for Infinion CX spinal cord stimulator leads on September 3, 2026.
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/25/2026 identifies Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic Catheters with status Recall Confirmed.
According to MedSun Newsletter, October 2026, the highlighted entry lists Boston Scientific Removes Imager II Angiographic Catheters 9/25/26.
According to Medical Device Recalls, Boston Scientific Corporation initiated a Class I recall for Imager II angiographic catheters on September 25, 2026.
Ventilator, breathing and infant-care actions on the list
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/23/2026 identifies Early Alert: Ventilator Issue from React Health with status Early Alert – FDA collecting information.
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/23/2026 identifies Early Alert: Heart Pump Controller Issue from Abiomed with status Early Alert – FDA collecting information.
According to MedSun Newsletter, October 2026, the highlighted entries list Early Alert: VOCSN Ventilator Issue from React Health 9/23/26 and Early Alert: Heart Pump Controller Issue from Abiomed 9/23/26.
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/21/2026 identifies Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets with status Recall Confirmed.
According to MedSun Newsletter, October 2026, the highlighted entry lists CooperSurgical Removes INCA Infant Nasal CPAP Sets 9/21/26.
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/01/2026 identifies Breathing Circuit Recall: Medline Removes Neonatal and Infant Heated Wire Breathing Circuits with status Recall Confirmed.
According to MedSun Newsletter, October 2026, the highlighted entry lists Medline Removes Neonatal and Infant Heated Wire Breathing Circuits 9/1/26.
Sodium chloride, kit and monitoring corrections
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/18/2026 identifies Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules with status Recall Confirmed.
According to MedSun Newsletter, October 2026, the highlighted entry lists Spectra Medical Removes Sodium Chloride Injection USP Ampules for removal of sodium chloride ampules manufactured by Huons Co., Ltd. 9/18/26.
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/21/2026 identifies Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Huons Sodium Chloride Ampules with status Recall Confirmed.
According to MedSun Newsletter, October 2026, the highlighted entry lists AVID Medical Issues Correction for Kits Containing Huons Sodium Chloride Ampules for removal of sodium chloride ampules manufactured by Huons Co., Ltd. 9/21/26.
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/24/2026 identifies Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules with status Recall Confirmed.
According to MedSun Newsletter, October 2026, the highlighted entry lists Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules for removal of sodium chloride ampules manufactured by Huons Co., Ltd. 9/24/26.
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/18/2026 identifies Nitric Oxide Delivery System Correction: NOxBOX Updates Use Instructions for NOxBOXi Nitric Oxide Delivery System with status Recall Confirmed.
According to MedSun Newsletter, October 2026, the highlighted entry lists NOxBOX Updates Use Instructions for NOxBOXi Nitric Oxide Delivery System 9/18/26.
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/15/2026 identifies Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device with status Recall Confirmed.
According to MedSun Newsletter, October 2026, the highlighted entry lists Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device 9/15/26.
According to Medical Device Recalls and Early Alerts | FDA, the entry dated 09/03/2026 identifies Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software with status Recall Confirmed.
According to MedSun Newsletter, October 2026, the highlighted entry lists GE HealthCare Updates Use Instructions for Portrait Core Services Software 9/3/26.
How FDA presents recalls and Early Alerts
The FDA page carries an update dated September 29, 2025 stating CDRH is expanding the Communications Pilot to Enhance the Medical Device Recall Program to include all medical devices.
The update refers readers to the What is an Early Alert? webpage for additional information.
The FDA page states that FDA lists the most serious type of medical device recalls, as well as early alert communications about corrective actions being taken by companies that FDA believes are likely to be the most serious type of recalls, on the website by the date FDA posts the information.
The FDA page states that FDA will keep the public informed and update the website as significant new information becomes available.