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.

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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	Date
Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety Communication	01/23/20
UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication	11/05/19
URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication	10/01/19
The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication	08/29/19
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

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
Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers	11/19/19
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
December 2, 2019 UPDATE: Latest Interim post-approval study (PAS) Results Are Available for the Abiomed Impella RP System	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
LivaNova Recalls VNS Therapy SenTiva Generator Due to Reset Error	12/20/19
GE Healthcare Recalls Giraffe Incubators and OmniBeds Due to Potential for Infants to Fall	12/17/19
Cook Medical Recalls CrossCath® Support Catheters Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling	12/17/19
Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor StallMedtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor Stall	12/16/19
Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm	11/07/19
Medtronic Recalls Remote Controllers for MiniMed Insulin Pumps for Potential Cybersecurity Risks	11/05/19
Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Become Detached	11/04/19
Abbot Recalls CentriMag Circulatory Support System Motor Due to Pump and Motor Issues	11/04/19
Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers for Failure to Completely Form Staples	10/30/19
Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer	09/12/19
Edwards Lifesciences, LLC, Recalls SAPIEN 3 Ultra Delivery System Due to Burst Balloons During Surgery, Which May Result in Vascular Injury, Bleeding, or Surgical Intervention	08/22/19
Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Containing Becton Dickinson Alaris Pump Model 8100 Infusion Sets Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster than Expected Delivery of Medication	08/21/19
Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack Containing Vyaire Medical enFlow Fluid Warming Disposable Cartridge Due to Potential Risk of Exposure to Elevated Levels of Aluminum	08/21/19
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

MORE MEDICAL DEVICE RECALLS