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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic, Temporary Pacing Lead System

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  Class 2 Device Recall Medtronic, Temporary Pacing Lead System see related information
Date Initiated by Firm June 16, 2016
Create Date September 19, 2016
Recall Status1 Terminated 3 on February 13, 2018
Recall Number Z-2200-2016
Recall Event ID 74424
510(K)Number K042190  
Product Classification Electrode, pacemaker, temporary - Product Code LDF
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.
Code Information Model 6416 Lot Number List: All Lots manufactured after 01May2014 as of 23May2016. Expiration dates through 12 April 2018.   AAG102212F AAG127214F AAG154212F AAG177226F AHH123209F AHH167209F AAG102219F AAG128219F AAG154219F AAG177229F AHH124209F AHH168208F AAG103213F AAG129214F AAG155210F AAG178227F AHH125207F AHH169209F AAG104212F AAG130210F AAG156210F AAG178230F AHH126209F AHH170208F AAG104219F AAG130213F AAG156213F AAG179228F AHH127209F AHH171209F AAG105210F AAG131212F AAG157212F AAG179231F AHH128209F AHH172207F AAG105213F AAG131219F AAG157219F AAG180227F AHH129209F AHH173208F AAG106219F AAG132213F AAG158212F AAG180230F AHH130209F AHH174209F AAG107210F AAG133211F AAG158219F AAG181228F AHH131207F AHH175208F AAG107213F AAG133214F AAG159214F AAG181231F AHH132209F AHH176208F AAG108211F AAG134214F AAG160211F AAG182226F AHH133208F AHH177209F AAG108214F AAG135219F AAG160214F AAG182229F AHH134209F AHH178208F AAG109219F AAG136211F AAG161210F AAG183230F AHH135209F AHH179209F AAG110211F AAG136214F AAG161213F AAG184231F AHH136207F AHH180209F AAG111210F AAG137211F AAG162210F AAG185230F AHH137208F AHH181207F AAG112212F AAG137214F AAG162213F AAG186231F AHH138207F AHH182207F AAG112219F AAG138210F AAG163212F AAG187229F AHH139209F AHH183209F AAG113211F AAG138213F AAG163219F AAG188229F AHH140208F AHH184209F AAG113214F AAG139212F AAG164210F AAG189230F AHH141209F AHH185209F AAG114219F AAG139219F AAG164213F AAG190229F AHH142208F AHH186209F AAG115212F AAG140210F AAG165212F AAG191230F AHH143208F AHH187209F AAG115219F AAG140213F AAG165219F AAG192230F AHH144209F AHH188209F AAG116210F AAG141211F AAG166211F AAG193231F AHH145207F AHH189207F AAG116213F AAG141214F AAG166214F AAG194229F AHH146207F AHH190209F AAG117211F AAG142210F AAG167212F AAG195231F AHH147208F AHH191209F AAG117214F AAG142213F AAG167219F AAG196230F AHH148208F AHH192209F AAG118212F AAG143210F AAG168211F AAG197231F AHH149209F AHH192290F AAG118219F AAG143213F AAG168214F AHH105208F AHH150209F AHH193207F AAG119211F AAG144211F AAG169210F AHH106208F AHH151208F AHH194209F AAG119214F AAG145212F AAG169213F AHH107209F AHH152209F AHH195209F AAG120212F AAG145219F AAG170219F AHH109209F AHH153207F AHH196208F AAG120219F AAG146214F AAG171210F AHH110208F AHH154207F AHH197209F AAG121212F AAG147219F AAG171213F AHH111209F AHH155208F AHH198207F AAG121219F AAG148210F AAG172219F AHH112209F AHH156209F KAB504209F AAG122210F AAG148213F AAG172228F AHH113209F AHH157207F KAB506212F AAG122213F AAG149210F AAG172231F AHH114207F AHH158208F KAB507211F AAG123210F AAG149213F AAG173228F AHH115207F AHH159209F KAB508212F AAG123213F AAG150210F AAG173231F AHH116207F AHH160209F KAB510208F AAG124212F AAG150213F AAG174227F AHH117208F AHH161209F KAB512212F AAG124219F AAG151212F AAG174230F AHH118207F AHH162207F KAB513209F AAG125212F AAG151219F AAG175226F AHH119209F AHH163207F KAB514209F AAG125219F AAG152210F AAG175229F AHH120209F AHH164209F KAB515208F AAG126211F AAG152213F AAG176228F AHH121207F AHH165208F KAB516209F AAG126214F AAG153211F AAG176231F AHH122208F AHH166209F KAB522209F
Recalling Firm/
Medtronic Inc., Cardiac Rhythm and Heart Failure
8200 Coral Sea St NE
Mounds View MN 55112-4391
For Additional Information Contact Medtronic CRHF Sales Representative.
Manufacturer Reason
for Recall
This Pacing Lead System does not comply with Section 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 Determined
Cause 2
Nonconforming Material/Component
Action Medtronic sent an Urgent Medical Device Recall letter dated June 2016 to affected customers. The letter was addressed to Health Care Professional. The letter described the problem and the product involved in the recall. The letter described the "Customer Actions" which advised consignees to identify, quarantine and return affected product to Medtronic. Customers were instructed to complete the enclosed Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or scan and e-mail to RS.CFQFCA@medtronic.com. For questions, please contact your Medtronic CRHF Sales Representative.
Quantity in Commerce 11697 (5523 OUS, 6174 US)
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LDF and Original Applicant = MEDTRONIC VASCULAR