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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 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 Date
The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication 07/24/19
Certain Medtronic MiniMed Insulin Pumps Have Potential Cybersecurity Risks: FDA Safety Communication 07/01/19
FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication 05/17/19
FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication 05/07/19
Mammography Problems at East Palestine Family Medical Clinic in East Palestine, Ohio: FDA Safety Communication 04/26/19
Use of the Stryker Wingspan Stent System Outside of Approved Indications Leads to an Increased Risk of Stroke or Death: FDA Safety Communication 04/25/19
The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication 04/12/19
The FDA Recommends Only Using Cleared or Approved Medical Devices to Help Assess or Diagnose a Head Injury, Including Concussion: FDA Safety Communication 04/10/19
The FDA Warns Against Use of Previously Owned Test Strips or Test Strips Not Authorized for Sale in the United States: FDA Safety Communication 04/08/19
Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication 04/03/19
UPDATE -- Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication 03/18/19
Caution When Using Robotically-Assisted Surgical Devices in Women's Health including Mastectomy and Other Cancer-Related Surgeries: FDA Safety Communication 03/05/19
FDA Warns Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer: FDA Safety Communication 02/27/19

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
Programmable CSF Shunts and Magnetic Field Interference with Implanted Hearing Devices - Letter to Health Care Providers 07/16/19
UPDATE On Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors - Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures 05/23/19
UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers 05/21/19
UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers 03/15/19
Safe Use of Surgical Staplers and Staples - Letter to Health Care Providers 03/08/19
Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) - Letter to Health Care Providers 02/06/19
Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers 02/04/19
Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers 01/17/19
Update Regarding Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry 11/08/18
Update Regarding Unintended Heating Associated with the Monteris Medical NeuroBlate Probe 11/08/19
Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers 11/01/18

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
Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Due to a "Low Priority" "Keep Vein Open (KVO), End of Infusion" Alarm and Multiple Software Errors 08/12/19
Abbott (Formerly St. Jude Medical Inc.), Recalls Ellipse Implantable Cardioverter Defibrillators Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy 08/05/19
QIAGEN Recalls Filter Tips for use with the QIAsymphony SP/AS Instruments Due to Potential to Leak, Which May Result in Delayed or Inaccurate Results 08/02/19
Centurion Medical Products Recalls Airway Kit containing Sheridan® Endotracheal Tubes Due to Potential for the Tube Connector to Dislodge, Which May Result in Disconnection of the Patient from the Breathing Circuit 08/02/19
Datascope/Getinge Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps (IABP) Due to Potential Battery Failure 07/23/19
Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion 07/18/19
Becton Dickinson (BD) Recalls Alaris Infusion Sets for the Alaris Pump Model 8100 Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster than Expected Delivery of Medication 07/18/19
Teleflex Recalls NEONATAL ConchaSmart Breathing Circuit Due to Circuit Cracks 07/17/19
Hamilton Medical AG Recalls Hamilton-G5 Ventilators Due to Potential for Sporadic Error Message Resulting in the Ventilator to Cease Ventilation and Enter Ambient State 07/12/19
GE Healthcare, LLC Recalls Giraffe Infant Warmers and Panda i-Res Infant Warmers Due to Bedside Panels and Latch Areas Cracking or Breaking 07/12/19
Becton Dickinson & Company (BD) Recalls SmartSite Syringe Administration Set Due to Risk of Leaks 07/01/19
Edwards Lifesciences Recalls the IntraClude Intra-Aortic Occlusion Device Due to Risk of Balloon Rupture 07/01/19
Vyaire Medical Recalls the enFlow Fluid Warming System Disposable Cartridges Due to Potential Risk of Exposure to Elevated Levels of Aluminum Exposure to Patients 06/27/19
Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit 06/21/19
Cook Incorporated Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter Due to Balloons Bursting Below the Rated Burst Pressure 06/18/19
Terumo Medical Corporation Recalls SOLOPATH® Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System Due to Dislodgement of the Fairing Tip from the Sheath 05/30/19
lntegra LifeSciences Recalls the LimiTorr Volume Limiting CSF Drainage System and the MoniTorr ICP External CSF Drainage and Monitoring System Due to Possible Breakage of the LimiTorr Transducer and MoniTorr Panel Mount Stopcock 05/24/19
Edwards Lifesciences LLC Recalls EV1000 Clinical Platforms Due to Electrical Short Circuit Which May Cause the Device to Stop Working or Catch Fire 05/24/19
Beckman Coulter Life Sciences Recalls DxH800 and DxH600 and DxH 900 Hematology Analyzers Due to Risk of Inaccurate Results 05/23/19

MORE MEDICAL DEVICE RECALLS



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