Z-2546-2016 Class II Terminated
FDA device recall Z-2546-2016 was initiated by Medtronic Cardiovascular Surgery-the Heart Valve Division on August 3, 2016 and is designated Class II. Reason for recall: Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). The recall status is terminated (terminated March 31, 2017). Affected quantity: 7,319 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2016
- Initiation Date
- August 3, 2016
- Termination Date
- March 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,319 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.