Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure Due to This Pacing Lead System does not comply with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc., Cardiac Rhythm and Heart Failure directly.
Affected Products
Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is disposable, for temporary single patient use, with a contemplated implant duration of 7 days or less. The system is used with Medtronic temporary external pacemakers.
Quantity: 11697 (5523 OUS, 6174 US)
Why Was This Recalled?
This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting a patients lead to a possible hazardous voltage.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc., Cardiac Rhythm and Heart Failure
Medtronic Inc., Cardiac Rhythm and Heart Failure has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report