Medtronic recalls Cobalt XT DR MRI SureScan defibrillators with model DDPA2D1 due to potential weld cracks causing manufacturing failures. Affected units have specific serial numbers and GTIN.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic is recalling a specific model of implantable defibrillator (Cobalt XT DR MRI SureScan, model DDPA2D1) because a manufacturing defect may cause weld cracks that fail during quality checks. This could lead to device malfunction if the device is used.
A manufacturing defect may cause weld cracks in the device that fail during the leak check step. This could lead to device malfunction if the device is used, but the risk is not immediate or severe under normal use conditions.
People with an implantable cardioverter defibrillator (ICD) that matches the model and serial numbers listed. Those with the specific serial numbers or GTIN are most at risk.
Check if your defibrillator has the model number DDPA2D1 and serial numbers RSL607245S, RSL607881S, RSL607883S, RSL607884S, or RSL607888S. The GTIN number 00763000178338 is also associated with this recall.
Verify your defibrillator's model number and serial numbers against the listed ones: DDPA2D1 and RSL607245S, RSL607881S, RSL607883S, RSL607884S, RSL607888S.
The model number is DDPA2D1.
The affected serial numbers are RSL607245S, RSL607881S, RSL607883S, RSL607884S, and RSL607888S.
The recall record does not specify a remedy.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2209-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2209-2024 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.
