Medical Device Recall: MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
Medtronic Inc. · April 16, 2024
Reason for Recall
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
3 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2201-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.