MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator

Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information: GTIN: 00763000001568, Serial Numbers: CWS604689S, CWS604691S, CWS604694S

Distribution pattern: 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.