FDA Device recall Z-2200-2016
Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416…
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416… by Medtronic Cardiac Rhythm And Heart Failure, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2200-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-16 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Model 6416 Lot Number List: All Lots manufactured after 01May2014 as of 23May2016. Expiration dates through 12 Apr…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 AAG1102 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2200-2016%22
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