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Medtronic Inc. recalls EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
Recalled July 3, 2024 · FDA recall Z-2196-2024 · Medtronic
Hazard
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. · FDA Class II
Units
1 unit
Sold at
Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Description
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Product
EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
Manufacturer(s)
Medtronic Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →