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Medical Devices

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Public Health Notifications


Public Health Notifications: Get e-mail updatesSubscribe

A Public Health Notification is an important message from the FDA’s Center for Devices and Radiological Health to the health care community describing a risk associated with the use of a medical device and providing recommendations to avoid or reduce the risk.

A Preliminary Public Health Notification is similar to a Public Health Notification. However, it is issued when the information we have is still evolving, but we believe that the health care community needs this early information to make informed clinical decisions. When we issue a Preliminary Public Health Notification, we intend to update it as important information or new recommendations become available.

We encourage readers to subscribe to email updates to receive email announcements when a new or revised Public Health Notification or Preliminary Public Health Notification is issued.

Also available: information on recalls, Archived Public Health Notifications, and additional FDA safety information from MedWatch.

Date Issued Title
08/13/2009

Potentially Fatal Errors with GDH-PQQ Glucose Monitoring Technology

See Related Document: Advice to Patients

03/05/2009

Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings

See Related Document

10/20/2008 Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence
9/24/2008 Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status
7/14/2008 Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning
7/1/2008 Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
3/17/2008 Updated Data on Mortality Associated with the Medtronic AneuRx® Stent Graft System
2/25/2008

Denture Cleanser Allergic Reactions and Misuse

See Related Document: Advice to Patients

1/15/2008 Unretrieved Device Fragments
12/12/2007 Patient Burns from Electric Dental Handpieces
12/4/2007 Vail Products Enclosed Bed Systems
10/31/2007 Avoiding Hazards with Using Cleaners and Disinfectants on Electronic Medical Equipment
10/10/2007

Importance of Vaccination in Cochlear Implant Recipients

See Related Document: Advice to Patients

8/13/2007 Repair, Service, or Testing May Not Have Been Performed on Certain Baxter COLLEAGUE and FLO-GARD Infusion Pumps
7/12/2007

Advice for Patients: Possible Burns or Fires from Heating Pads Manufactured by HoMedics, Inc.

See Related Document: Questions and Answers on HoMedics®, Inc. Heating Pads and General Heating Pad Safety (7/24/2007)

See Related Document: Public Health Advisory: Hazards Associated With The Use of Electric Heating Pads
(NOTE: Although this Advisory was released in 1995, the recommendations are still valid.)

5/31/2007

Acanthamoeba Keratitis Infections Potentially Related to Complete MoisturePlus Multipurpose Contact Lens Solution Manufactured by Advanced Medical Optics (AMO)

See Related Document: Advice to Patients

5/18/2007

Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Devices Manufactured by Shelhigh, Inc.

See Related Document: Advice to Patients

3/1/2007

Unpredictable Events in Medical Equipment due to New Daylight Saving Time Change

See Related Document: Advice to Patients

2/27/2007
Updated
7/16/2007
Updated Information on Custom Ultrasonics, Inc., Endoscope Washer/Disinfector
2/1/2007 Precautions in Using the Reintroduced Vapotherm® 2000i [Respiratory Gas Humidifier] System
6/19/2006
Updated 6/22/2006
Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures
4/24/2006
Updated 6/19/2006
Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals
4/10/2006
Updated 5/31/2006

Fungal Keratitis Infections Related to Contact Lens Use

See Related Document: Advice to Patients

2/27/2006 Update: Gambro Prisma® Continuous Renal Replacement System
2/06/2006

Continued Risk of Bacterial Meningitis in Children with Cochlear Implants with a Positioner Beyond Twenty-Four Months Post-Implantation

See Related Document: Advice to Patients

12/28/2005

Second Update: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators

See Related Document: Advice to Patients

11/16/2005 Risk of Electromagnetic Interference with Medical Telemetry Systems Operating in the 460-470 MHz Frequency Bands
10/13/2005
(See 12/28/05 Update)

Update: Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators

See Related Document: Advice to Patients

7/29/2005 Complications from Metallic Tracheal Stents in Patients with Benign Airway Disorders
7/14/2005
(See 12/28/05 Update)

Guidant VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators

See Related Document: Advice to Patients

11/25/2003
Updated 10/18/2004
Final Update of Information for Physicians on Sub-acute Thromboses (SAT) and Hypersensitivity Reactions with Use of the Cordis CYPHER™ Sirolimus-eluting Coronary Stent
3/25/2005
Updated 6/24/2005
Vail Products Enclosed Bed Systems
5/10/2005 MRI-Caused Injuries in Patients with Implanted Neurological Stimulators
10/31/2002
Updated 5/7/2004
Complications Related to the Use of Bone Cement and Bone Void Fillers in Treating Compression Fractures of the Spine
12/19/2003
Updated 5/7/2004
Counterfeit Polypropylene Mesh
4/2/2004 Paralysis from Absorbable Hemostatic Agent
12/18/2003
Updated 3/30/2004
Safety Tips for Preventing Hospital Bed Fires
12/17/2003 Updated Data on Mortality Associated with Medtronic AVE AneuRx® Stent Graft System
12/19/2002 Diathermy Interactions with Implanted Leads and Implanted Systems with Leads
10/23/2002 Non-Corrective Decorative Contact Lenses Dispensed Without a Prescription
7/12/2002 PVC Devices Containing the Plasticizer DEHP
11/2/2001 Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients
7/20/2001 Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels
4/27/2001 Problems with Endovascular Grafts for Treatment of Abdominal Aortic Aneurysm (AAA)
3/13/2001 Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers
10/11/2000 Serious Injuries from Microwave Thermotherapy for Benign Prostatic Hyperplasia
8/29/2000 Potential for Injury from Circumcision Clamps
7/10/2000 Risk of Electromagnetic Interference with Medical Telemetry Systems
10/8/1999 Complications Related to the Use of Vascular Hemostasis Devices
9/10/99 Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System
5/11/99 Potential Cross-Contamination Linked to Hemodialysis Treatment
5/4/99 Hypotension and Bedside Leukocyte Reduction Filters
2/22/99 Glass Capillary Tubes: Joint Safety Advisory About Potential Risks
2/4/99 Explosions and Fires in Aluminum Oxygen Regulators
10/8/98 NIR ON Ranger w/SOX Premounted Stent System
9/28/98 Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators
8/3/98 Electrical Hazards Associated With Lead Wires and Cables
5/21/98 Need for CAUTION When Using Vacuum Assisted Delivery Devices
4/13/98 Warning Regarding the Use of the AbTox Plazlyte™ Sterilization System
3/20/98 Interference Between Digital TV Transmissions and Medical Telemetry Systems
3/13/98 Potential Hypersensitivity Reactions To Chlorhexidine-Impregnated Medical Devices
3/12/98 Supplemental Information Regarding: Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera
2/13/98 Failure of Isocam II, Dual-Headed Nuclear Medicine Gamma Camera
8/13/97 Vacuum Loss in Electronic Resonating Components
7/25/97 Limitations of Toxoplasma IgM Commercial Test Kits
7/7/97 Assays for Antibodies to Borrelia burgdorferi; Limitations, Use, and Interpretation for Supporting a Clinical Diagnosis of Lyme Disease
5/21/97 Steam Re-Sterilization Causes Deterioration of Zirconia Ceramic Heads of Total Hip Prostheses
4/17/97 Potential Infection Problem With Medical Devices Rented or Leased by Health Care Facilities
3/24/97 Risks of Devices for Direct Detection of Group B Streptococcal Antigen
12/16/96 Important Information Relating to Cellulose Acetate Dialyzers
6/27/96 Potential Risk of Spontaneous Combustion in Large Quantities of Patient-Examination Gloves
12/12/95 Hazards Associated With The Use of Electric Heating Pads
10/16/95 Retinal Photic Injuries From Operating Microscopes During Cataract Surgery
8/23/95 Entrapment Hazards With Hospital-Bed Side Rails
7/15/94 Important Information About TMJ Implants
9/30/94 Avoidance of Serious X-Ray-Induced Skin Injuries to Patients During Fluoroscopically Guided Procedures
4/18/94 Hazards of Precipitation Associated With Parenteral Nutrition
3/1/94 Avoiding Injuries From Rapid Drug or I.V. Fluid Administration Associated With I.V. Pumps And Rate-Controller Devices
2/28/94 Occluded Endotracheal Tubes
12/28/93 Unsafe Electrode Lead Wires and Patient Cables Used With Medical Devices
9/15/93 Hazards of Volume Ventilators and Heated Humidifiers  
9/3/93 Unsafe Patient Lead Wires and Cables
8/19/93* Fluoride Contamination of Hemodialysis Water Supply
7/14/93 Hazards of Heated-Wire Breathing Circuits
11/25/92 MRI-Related Death of Patient With Aneurysm Clip
10/23/92 Important Information About New Studies on Dialyzer Germicides
7/15/92 Potential Hazards With Restraint Devices
5/29/92 Caude Equina Syndrome - Use of Catheters
5/20/92 Aluminum and Other Trace-Element Contamination in Dialysis Facilities
4/21/92 Important Information on Shiley CC Valve Fractures
4/16/92 Needlestick and Other Risks From Hypodermic Needles on Secondary I.V. Administration Sets - Piggyback and Intermittent I.V.
3/6/92 Anaphylactoid Reactions Associated With ACE Inhibitors and Dialyzer Membranes
9/91 Vitek Proplast Temporomandibular Joint Implants
12/28/90 Serious Problems With Proplast-Coated TMJ Implant
8/28/90 Hepatitis B Transmission Via Spring-Loaded Lancet Devices
5/11/90 Gas/Air Embolism Associated With Intrauterine Laser Surgery
2/16/90 Important Tips for Apnea Monitor Users
5/30/89 New FDA Recommendations & Results of Contact Lens Study
3/15/89 Sodium Azide Contamination of Hemodialysis Water Supplies
1/24/89 Homemade Saline Solutions for Lenses
2/19/88 Chloramine Contamination of Hemodialysis Water Supplies
4/28/87 Possibly Contaminated Dura Mater
6/19/85 Apnea Monitors
3/28/85 Defibrillator Batteries
11/30/83 Dialyzer: First-Use Syndrome
9/2/83 Breathing System Connectors
6/16/83 Electrically Powered Hospital Beds
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