Medtronic Inc. Recall 94674
Description: COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Medtronic Inc. Recall 94674 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2190-2024 |
| Event ID | 94674 |
| Event Description | COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator |
| Product Type | Devices |
| 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. |
| Quantity | 14 |
| Recall Reason | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| Device Classification | 20240703 |
| Device Code Info | GTIN: 00763000178192, Serial Numbers: RTK624593S, RTK624594S, RTK624595S, RTK624596S, RTK624597S, RTK624599S, RTK624601S, RTK624602S, RTK624603S, RTK624604S, RTK624606S, RTK624607S; GTIN: 00763000711207, Serial Numbers: RTK624400S, RTK624405S. |
| Center Classification Date | 20240626 |
| Recall Initiation Date | 20240416 |
| Recalling Firm | Medtronic Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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