Medtronic recalls specific Implantable Cardioverter Defibrillators (COBALT DR MRI SureScan model DDPB3D1) due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers and GTIN.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic is recalling certain Implantable Cardioverter Defibrillators (ICDs) that may have a manufacturing defect causing weld cracks. This could lead to device failure during the leak check process. Affected units have specific serial numbers and a GTIN.
The device may have a weld crack that causes it to fail during the leak check step in manufacturing. This defect could lead to the device not functioning properly after implantation.
People with the recalled Implantable Cardioverter Defibrillator model DDPB3D1 are affected. Those who have this specific device are at risk due to the potential manufacturing defect.
Check if your device has the model number DDPB3D1 and the listed serial numbers (RSN604373S through RSN604386S). The GTIN is 00763000711306.
Verify your device's model number and serial number against the list provided in the recall notice.
The model number is DDPB3D1.
The affected serial numbers are RSN604373S, RSN604374S, RSN604375S, RSN604376S, RSN604378S, RSN604380S, RSN604383S, RSN604385S, and RSN604386S.
The GTIN is 00763000711306.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2206-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2206-2024 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
