Reported Jul 20, 2016 · Terminated
Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack…
Medtronic Inc., Cardiac Rhythm and Heart Failure
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure · 8200 Coral Sea St NE · Mounds View, MN · 55112-4391
Is this the product you have?
- Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO
- Product Catalog NumbersFive (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
- Lot codes and dates
- Model 6416 Lot Number ListAll Lots manufactured after 01May2014 as of 23May2016. Expiration dates through 12 April
265 of 265 codes
2018.AAG102212FAAG127214FAAG154212FAAG177226FAHH123209FAHH167209FAAG102219FAAG128219FAAG154219FAAG177229FAHH124209FAHH168208FAAG103213FAAG129214FAAG155210FAAG178227FAHH125207FAHH169209FAAG104212FAAG130210FAAG156210FAAG178230FAHH126209FAHH170208FAAG104219FAAG130213FAAG156213FAAG179228FAHH127209FAHH171209FAAG105210FAAG131212FAAG157212FAAG179231FAHH128209FAHH172207FAAG105213FAAG131219FAAG157219FAAG180227FAHH129209FAHH173208FAAG106219FAAG132213FAAG158212FAAG180230FAHH130209FAHH174209FAAG107210FAAG133211FAAG158219FAAG181228FAHH131207FAHH175208FAAG107213FAAG133214FAAG159214FAAG181231FAHH132209F
- Model 6416 Lot Number ListAll Lots manufactured after 01May2014 as of 23May2016. Expiration dates through 12 April
- Amount recalled
- 11697 (5523 OUS, 6174 US)
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc., Cardiac Rhythm and Heart Failure recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.