Recall Z-2200-2024 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Medtronic Inc.
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
| Date | Jun 26, 2024 (initiated Apr 16, 2024) |
| Status | Open, Classified |
| Reason | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. |
| Root 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 | 2 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, Mol |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.