FDA-Device2021-04-07Class I

Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillat

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard

A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

Sold states
Worldwide Distribution: US (nationwide) Including Puerto Rico and countries of: Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guadeloupe, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Montenegro, Morocco, Namibia, Nepal, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam Virgin Islands (British), Yemen and Zimbabwe.
Affected count
238393 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3) Amplia family: Amplia MRI CRT-D and Amplia MRI Quad CRT-D models; 4) Compia family: Compia MRI CRT-D model; 5) Brava family: Brava CRT-D and Brava Quad CRT-D models (OUS only); Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide cardiac resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1306-2021

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