2016 Medical Device Recalls in America

By Staff Writer

Millions of Americans rely on medical devices or equipment for protecting their well-being and quality of life. However, the chance of one of these devices being recalled is also a factor. This can become a bigger problem if medical device users are unaware that their devices have been recalled.

Here, we offer a complete list of the medical device recalls from 2016 – including the date the recall was enacted.

Product	Date of Recall
Greatbatch Medical Recalls Standard Offset Cup Impactor Used for Hip Joint Replacement due to Inadequate Sterilization	12/16/16
Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate	12/09/16
Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating	11/30/16
SentreHeart Recalls FindrWIRZ Guidewire System due to Coating Separation	11/22/16
HeartWare Recalls Ventricular Assist Device Controllers Due to Loose Connector Ports	11/16/16
HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues	11/16/16
Customer Letter for the Class II Teleflex LMA Mucosal Atomization Devices. (PDF – 76KB)	11/09/16
St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion	10/24/16
TeleFlex Medical Recalls Tracheostomy Tube Set Due to Possible Disconnection During Patient Use	10/20/16
Leonhard Lang Multi-function Defibrillation Electrodes DF29N Will Not Work with Welch Allyn Automatic External Defibrillator model AED 10	10/14/16
Baxter Corporation Recalls 50 mm 0.2 Micron Filter Due to the Potential for a Missing Filter Membrane and Possible Particulate Matter Contamination	10/06/16
DePuy Synthes Recalls Power Tool System Battery Adaptors Due to Possible Explosion Risk	09/28/16
Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination	09/06/16
Alere Recalls INRatio® and INRatio2® PT/INR Monitoring System Due to Incorrect Test Results	08/25/16
BioMerieux SA Alerts Customers about Potential Inaccurate Test Results When using NucliSENS® easyMAG® Magnetic Silica for Nucleic Acid Extraction	08/12/16
Dräger Recalls VentStar Oxylog 3000 Pediatric Patient Breathing Circuit Due to Potential Valve Leakage	08/04/16
CareFusion Recalls AVEA Ventilator Due to an Electrical Issue Which May Cause an Unexpected Shutdown	07/28/16
Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) Recalls Flush Angiographic Catheter Due to Tip Separation	07/22/16
HeartWare Inc. Extends Recall to Include Batteries Used in the Ventricular Assist Device Due to Premature Power Depletion	06/29/16
Medtronic Respiratory and Monitoring Solutions Recalls Battery Pack Used on Patient Monitors Due to Potential Fire Risk	05/27/16
Hummingbird Med Devices Inc. Recalls Hummi Micro-Draw Blood Transfer Device Due to Potential for Parts to Disconnect	05/26/16
B. Braun Medical Inc. Recalls Dialog+ Hemodialysis Systems Due Defective Conductivity Sensors	05/04/16
Boston Scientific Corporation Recalls Fetch 2 Aspiration Catheter Due to Shaft Breakage	04/19/16
Vascular Solutions Recalls Guardian II Hemostasis Valve Due to Low Pressure Seal Defect	04/13/16
Focus Diagnostics Recalls Laboratory Examination Kits Due to Inaccurate Test Results	04/13/16
Dexcom Inc. Recalls G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers Due to Audible Alarm Failure	04/11/16
Cook Medical Recalls Central Venous Catheter and Pressure Monitoring Sets and Trays due to Tips that May Split or Separate	03/30/16
Verathon Inc. Recalls GlideScope Titanium Single-Use Video Laryngoscope Due to Potential Video Feed Disruption	03/18/16
Arrow International Inc. Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Due to Sheath Separation Issue	03/17/16
Abbott Vascular Recalls MitraClip Clip Delivery System Due to Issue with Delivery System Deployment Process	03/15/16
Dräger Evita V500 and Babylog VN500 Ventilators – Recall Expanded to Include Optional PS500 Batteries with New Power Supply Firmware	03/03/16
Cook Medical Expands Recall for Beacon Tip Angiographic Catheters to Include Additional Product Lots	02/25/16
Dräger Medical Inc. Recalls Emergency Transport Ventilators Due to a System Error that may lead to a Halt in Ventilation Therapy	02/10/16
Arkray Recalls SPOTCHEM II Test Strips Due to Inaccurate Blood Sugar Readings	01/28/16
Thornhill Research Inc. Recalls MOVES Ventilator System Due to Battery Problem	01/27/16
St. Jude Medical Recalls Optisure Dual Coil Defibrillation Leads Due to Damage that May Prevent Patient Therapy	01/26/16
Brainlab Cranial Image-Guided Surgery (IGS) System – Navigation Inaccuracy	01/15/16
Stryker Fuhrman Pleural and Pneumopericardial Drainage Sets – Catheter May Break During Insertion	01/11/16
Dräger Evita V500 and Babylog VN500 Ventilators – Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly	01/05/16

If you feel you or a loved one has been injured by a defective medical device, the Tennessee defective products lawyers at Gilreath & Associates can help. We’ve assisted many clients across the country in receiving compensation for their injuries. Contact us today for a free consultation.

Posted in Uncategorized | No Comments »