CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1522-2021.
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1522-2021.
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., Cardiac Rhythm And Heart Failure (crhf) 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-1522-2021.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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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., Cardiac Rhythm And Heart Failure (crhf) Recall FAQ
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf) is the subject of a medical implants safety report: CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).. The notice was published on April 6, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 16,311 units are potentially affected.