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Medtronic Inc. Recall 94674

Description: MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator

Medtronic Inc. Recall 94674 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2205-2024
Event ID94674
Event DescriptionMIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Product TypeDevices
DistributionWorldwide - 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.
Quantity13 units
Recall ReasonPotential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Device Classification20240703
Device Code InfoGTIN: 00763000611989, Serial Numbers: CWR621520S, CWR621521S, CWR621522S, CWR621523S, CWR621524S, CWR621525S, CWR621526S, CWR621527S, CWR621528S, CWR621529S, CWR621530S, CWR621531S, CWR621532S.
Center Classification Date20240626
Recall Initiation Date20240416
Recalling FirmMedtronic Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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