Reported Sep 18, 2019 · Terminated
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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 (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
Medtronic Micra MC1VR01Single chamber transcatheter pacing systemREF MC1VR01US (US only). Cardiac pacemaker
- Lot codes and dates
REF MC1VR01USGTIN 00643169529748
- Serial NumbersMCR
2,712 of 2,712 codes
MCR610462SMCR610483SMCR610486SMCR610498SMCR610503SMCR610514SMCR610516SMCR610517SMCR610523SMCR610525SMCR610526SMCR610527SMCR610529SMCR610533SMCR610537SMCR610538SMCR610542SMCR610543SMCR610546SMCR610547SMCR610551SMCR610554SMCR610555SMCR610556SMCR610557SMCR610567SMCR610569SMCR610570SMCR610571SMCR610572SMCR610577SMCR610579SMCR610582SMCR610583SMCR610584SMCR610586SMCR610587SMCR610592SMCR610593SMCR610595SMCR610598SMCR610599SMCR610600SMCR610605SMCR610608SMCR610614SMCR610615SMCR610618SMCR610635SMCR610642SMCR610643SMCR610645SMCR610646SMCR610647SMCR610649SMCR610653SMCR610655SMCR610656SMCR610657SMCR610659S
- Amount recalled
- 24521 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
This product could cause temporary or reversible health problems — stop using it.
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