Reported Sep 23, 2015 · Terminated
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
Medtronic Inc. Cardiac Rhythm Disease Management
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 Disease Management · 8200 Coral Sea St NE · Saint Paul, MN · 55112-4391
Is this the product you have?
- Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
- Lot codes and dates
- serial numbers
138 of 138 codes
5K00055K00065K00075K00095K00105K00115K00125K00135K00145K00155K00165K00175K00185K00195K00205K00215K00225K00235K00245K00255K00265K00275K00285K00295K00305K00315K00325K00335K00345K00355K00365K00375K00395K00405K00415K00425K00435K00445K00455K00465K00475K00485K00535K00545K00565K00575K00585K00595K00625K00635K00645K00655K00665K00675K00685K00695K00705K00715K00725K0073
- serial numbers
- Amount recalled
- 103 units
Where it was sold
- Nationwide
Why it was recalled
An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.
This product could cause temporary or reversible health problems — stop using it.
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