FDAJune 16, 2016device
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 cont...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
medtronic inc cardiac rhythm and heart failuremedtronicmedtronic inc
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCMissry Associates Recalls Misco Sports Badminton Toy Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys2026-05-14
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