Medical Devices

Safety Communications

 

Medical Device Safety Communications

Medical Device Safety CommunicationDate
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

DeviceDateTitle
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]

Page Last Updated: 07/31/2015
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