Medical Devices

Safety Communications


Medical Device Safety Communications

Medical Device Safety CommunicationDate
Problem with Quality of Mammograms at Boston Diagnostic Imaging in Orlando, Florida: FDA Safety Communication 08/17/15
Serious Adverse Events with Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication 08/05/15
Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication 08/04/15
Cybersecurity Vulnerabilities of Hospira Symbiq Infusion System: FDA Safety Communication 07/31/15
Use of LARIAT Suture Delivery Device for Left Atrial Appendage Closure: FDA Safety Communication 07/13/15
Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication 05/28/15
Vulnerabilities of Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems: FDA Safety Communication 05/13/15
Problem with Quality of Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication 04/30/15
Problem with Quality of Mammograms at J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology in Huntington Park, California: FDA Safety Notification 04/13/15
Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes 03/26/15
Problems with Quality of Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication 03/24/15
Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication 02/19/15
Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients under Age 18 – FDA Safety Communication 01/21/15
UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication 11/24/14
Adverse Events Associated with Use of Enhancement Medical's "Expression" Intranasal Splint as a Dermal Filler 08/05/14
Mammography Problems at Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication 06/23/14
Product Shortage of Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication 05/23/14
Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication 05/07/14
Shasta Technologies GenStrip Blood Glucose Test Strips May Report False Results: FDA Safety Communication 04/29/14
Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication [ARCHIVED] 04/17/14
Breast Cancer Screening - Nipple Aspirate Test Is Not An Alternative To Mammography: FDA Safety Communication 12/12/13
Philips HeartStart Automated External Defibrillators (AED): FDA Safety Communication 12/03/13
Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder (ASO): FDA Safety Communication 10/17/13
Mammography Problems at San Sebastian X-Ray in San Sebastian, Puerto Rico: FDA Safety Communication 06/27/13
Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication 06/13/13
Stolen Covidien Surgical Stapler Reloads: FDA Safety Communication 05/07/13
Damaged or Worn Covers for Medical Bed Mattresses Pose Risk of Contamination and Patient Infection: FDA Safety Communication 04/19/13
Neptune 1 Silver Waste Management System and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Updated FDA Safety Communication 03/27/13
Metal-on-Metal Hip Implants: FDA Safety Communication 01/17/13
UPDATE on Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators Revised Expiration Dates: FDA Safety Communication [ARCHIVED] 11/08/12
Medisound, Inc./Digital Radiology Center, in Kissimmee, Florida Performing Mammography Without an MQSA Certificate: FDA Safety Communication [ARCHIVED] 09/28/12
Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc.: FDA Safety Communication [ARCHIVED] 08/16/12
Narrowed Indications for Use for the Stryker Wingspan Stent System: FDA Safety Communication [ARCHIVED] 08/08/12
Catheter Entrapment with the ev3 Onyx Liquid Embolic System: FDA Safety Communication [ARCHIVED] 06/28/12
UPDATE on Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection: FDA Safety Communication [ARCHIVED] 06/08/12
Blunt-Tip Surgical Suture Needles Reduce Needlestick Injuries and the Risk of Subsequent Bloodborne Pathogen Transmission to Surgical Personnel: FDA, NIOSH and OSHA Joint Safety Communication [ARCHIVED] 05/30/12
Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis: FDA Safety Communication [ARCHIVED] 05/25/12
Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients: FDA Safety Communication [ARCHIVED] 05/10/12
Choking Hazard and Serious Injuries with the Spinbrush line of Powered Toothbrushes: FDA Safety Communication [ARCHIVED] 02/16/12
Illegal Sale of Potentially Unsafe Hand-held Dental X-Ray Units: FDA Safety Communication [ARCHIVED] 02/10/12
UPDATE on Life-Threatening Injuries Associated with the ShoulderFlex Massager: FDA Safety Communication [ARCHIVED] 12/21/11
Use of Jet Injectors with Influenza Vaccines: FDA Safety Communication [ARCHIVED] 10/21/11
Preventing Surgical Fires: FDA Safety Communication [ARCHIVED] 10/13/11
Life-Threatening Injuries Associated with the ShoulderFlex Massager: FDA Safety Communication [ARCHIVED] 08/25/11
UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication [ARCHIVED] 07/13/11
Breast Cancer Screening - Thermography is Not an Alternative to Mammography: FDA Safety Communication [ARCHIVED] 06/02/11
Weck Hem-o-Lok Ligating Clips Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy: FDA and HRSA Joint Safety Communication [ARCHIVED] 05/05/11
UPDATE on Serious Complications Associated with Negative Pressure Wound Therapy Systems: FDA Safety Communication [ARCHIVED] 02/24/11
Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: FDA Safety Communication [ARCHIVED] 01/26/11
Removing Retrievable Inferior Vena Cava Filters: Initial Communication [ARCHIVED] 08/09/10
Preventing Cross-Contamination in Endoscope Processing: FDA Safety Communication [ARCHIVED] 11/19/09
Energy Levels in External Biphasic Defibrillators: Initial FDA Safety Communication [ARCHIVED] 11/05/09
Cybersecurity for Networked Medical Devices is a Shared Responsibility: FDA Safety Reminder [ARCHIVED] 11/04/09
Safety Investigation of Certain Medical Device Power Cords: Initial FDA Safety Communication [ARCHIVED] 10/19/09
Philips Lifeline Personal Help Button: FDA Safety Communication [ARCHIVED] 09/21/09
Philips Avalon Fetal Monitors: FDA Safety Communication [ARCHIVED] 09/04/09
Ongoing Safety Review of Arthroscopic Shavers: FDA Safety Communication [ARCHIVED] 07/06/09
Surgical Mesh: FDA Safety Communication [ARCHIVED] 10/21/08
Boston Scientific / Guidant Recall - Questions: FDA Safety Communication [ARCHIVED] 04/10/07
Laparoscopic Trocar Injuries: A report from a U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Systematic Technology Assessment of Medical Products (STAMP) Committee: FDA Safety Communication [ARCHIVED] 11/07/03
MRI Safety: FDA Safety Communication [ARCHIVED] 09/18/01

Articles/Safety Tips

Intense Pulsed Light 03/01/12 Safety tips for intense pulsed light therapy [ARCHIVED]
Ventilators 09/06/11 Take Precautions with Audible Alarms on Ventilators [ARCHIVED]
Infusion Pumps 03/01/11 "Smart" Infusion Pumps are Selectively Intelligent [ARCHIVED]
Phototherapy 02/23/11 Infant Phototherapy Light [ARCHIVED]
Enteral Devices 11/19/10 Reduce - and Report - Enteral Feeding Tube Misconnections [ARCHIVED]
Resectoscopes 09/24/10 Resectoscopes for Infants and Babies [ARCHIVED]
Microneurosurgical Clips 09/24/10 Aesculap AVM Micro Clip [ARCHIVED]
Wound Therapy 09/01/10 Negative pressure wound therapy: Use with care [ARCHIVED]
Skin Grafts 07/20/10 Air or Electric Dermatome Instruments [ARCHIVED]
Infusion 06/07/10 Chondrolysis Linked to Intra-articular Infusions [ARCHIVED]

Medical Device Safety Archive

The articles, patient alerts, safety communications and public health notifications in the sections below are no longer being reviewed or updated. The information in them may no longer be correct. Items that have been replaced will have a link to up-to-date information

Page Last Updated: 08/18/2015
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