MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2202-2024.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2202-2024.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Medtronic Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2202-2024.
Medtronic Inc.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Medtronic Inc. Recall FAQ
Medtronic Inc. is the subject of a medical implants safety report: MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator. The notice was published on April 16, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 26 units are potentially affected.