For Consumers

Resources for You

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

MedWatch Safety Alerts for Cardiovascular Devices

MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professionals and patients.

For additional information, see Medical Device Safety

2013

Product Name	Date Issued/Updated
Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves: Class I Recall - Risk of Air Being Introduced Into Device	03/27/2013

2012

Product Name	Date Issued/Updated
Alere Triage Diagnostic Tests (Multiple Tests): Class I Recall - Potential for Significantly Decreased Precision	07/11/2012
Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Component	03/02/2012
HeartSine Samaritan Public Access Defibrillator 300/300P: Class I Recall - Device May Intermittently Turn On and Off	11/19/2012
Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result	04/24/2012
St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication - Premature Insulation Failure	08/16/2012

2011

Product Name	Date Issued/Updated
AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I Recall	01/05/2011
Arstasis One Access System: Class I Recall - Components May Fracture and/or Separate	02/09/2011
Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall – Catheter Tip Can Break Inside of the Patient	06/14/2011
Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall - Insufficient Adhesive	04/01/2011
Maquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall – Shuts Off Without Warning	06/14/2011
Merit Prelude Short Sheath Catheter Introducer: Class I Recall - Tip May Detach During Use	02/04/2011
Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 Recall	04/01/2011
St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall - Failures with Lead Insulation	12/21/2011
Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall – Fragments of Adhesive and Plastic in the Cannula Tip May Embolize	06/14/2011

2010

Product Name	Date Issued/Updated
6 French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub	08/13/2010
Abiomed AB5000 Circulatory Support System: Class I Recall	03/10/2010
AngioSculpt "EX" PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall - Risk of Catheter Separation	09/08/2010
Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall	03/11/2010
Boston Scientific Implantable Cardioverter Defibrillators: Recall	03/19/2010
Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall	04/27/2010
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall	02/09/2010
Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall	06/09/2010
LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.	04/22/2010
LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure	07/02/2010
Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical	02/04/2010

2009

Product Name	Date Issued/Updated
Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters	04/15/2009
Biosite brand Triage Cardiac Panel	05/08/2009
Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication	11/19/2009
Cardiovascular Systems ViperSheath Sheath Introducer - Recall	11/17/2009
Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall	11/09/2009
External Biphasic Defibrillators Energy Levels: Initial Communication	11/10/2009
LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)	09/16/2009
Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers	06/11/2009
Philips Heartstart Fr2+ Automated External Defibrillators - Recall	10/05/2009
POWERSAIL Coronary Dilatation Catheters	07/30/2009
ZOLL AED Plus Defibrillator	04/09/2009