Home / Recalls / Medical Devices
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
Recalled July 20, 2016 · FDA recall Z-2200-2016 · Medtronic Inc., Cardiac Rhythm and Heart Failure
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. · FDA Class II
Units
11697 (5523 OUS, 6174 US)
Sold at
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 Federation, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, St Maarten, Sweden, Switzerland, Tajikistan, Turkey, Uganda, United Arab Emirates, United Kingdom, and US Virgin Islands.
Description
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.
Product
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.
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →