Medtronic Inc., Cardiac Rhythm and Heart Failure recalls Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 641…

Recall date

June 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2200-2016

FDA classification

Class II

Brand / firm

Medtronic Inc., Cardiac Rhythm and Heart Failure

Sold / distributed

Worldwide Distribution. US nationwide, Albania, Algeria, Australia, Botswana, Bulgaria, Canada, Colombia, France, Gabon, Germany, Guam, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Kazakhstan, Macedonia, Mauritius, Netherlands, Netherlands Antilles, Norway, Poland, Portugal, Qatar, Russian F…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.