Class 2 Device Recall Cobalt XT HF CDTD MRI SureScan

• Date Initiated by Firm: April 16, 2024
• Date Posted: June 26, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2192-2024
• Recall Event ID: 94674
• PMA Number: P010031S674
• Product Classification: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
• Product: Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
• Code Information: GTIN: 00763000178130, Serial Numbers: RTG612496S, RTG612497S, RTG612498S, RTG612499S, RTG612502S, RTG612503S, RTG612504S, RTG612505S, RTG612509S, RTG612512S, RTG612513S, RTG612549S, RTG612553S, RTG612556S.
• Recalling Firm/ Manufacturer: Medtronic Inc.; 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: Tracy McNulty; 763-505-6000
• Manufacturer Reason for Recall: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On about 04/18/2024, Medtronic notified customers that they were retrieving distributed units that may have undergone a specific manufacturing sequence that requires additional engineering evaluation. They requested that customers acknowledge the letter with signature.
• Quantity in Commerce: 14 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NIK; PMAs with Product Code = NIK