Z-2041-2021 Class II Ongoing
FDA device recall Z-2041-2021 was initiated by Medtronic Heart Valves Division on June 11, 2021 and is designated Class II. Reason for recall: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020. The recall status is ongoing. Affected quantity: Total of all Delivery Systems (Globally) = 67,339 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 14, 2021
- Initiation Date
- June 11, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total of all Delivery Systems (Globally) = 67,339 units
Product Description
Reason for Recall
Distribution Pattern
U.S.: AL, AK, AR, AZ, CA, CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Albania, Argentina, Australia, Austria, Belarus, Belgium, Brazil, BULGARIA, Canada, Chile, CHINA, Colombia, COSTA RICA, Croatia, Curacao, CYPRUS, Czech Republic, Denmark, DOMINICAN REPUBLIC, Egypt, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, Germany, Greece, GUATEMALA, HONDURAS, Hong Kong, Hungary, ICELAND, India, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), Ireland, Israel, Italy, Japan, JORDAN, KAZAKHSTAN, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LITHUANIA, Luxembourg, MACEDONIA (THE FORMER YUGOSLAV REPUBLIC OF), Malaysia, MALTA, Mexico, MOLDOVA (REPUBLIC OF), Montenegro, Netherlands, New Zealand, Norway, OMAN, Panama, Peru, Poland, Portugal, QATAR, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, SLOVAKIA (Slovak Republic), SLOVENIA, South Africa, Spain, Sweden, Switzerland, SYRIAN ARAB REPUBLIC, Taiwan (Republic of China), THAILAND, Turkey, UNITED ARAB EMIRATES, United Kingdom, URUGUAY, UZBEKISTAN, VENEZUELA and Viet Nam.