Reported Sep 18, 2019 · Terminated
Medtronic Micra MC1VR01, REF MC1VR01 (OUS 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 MC1VR01REF MC1VR01 (OUS only). Cardiac pacemaker
- Lot codes and dates
- GTIN 00643169529731
- Serial Numbers
2,714 of 2,714 codes
MCR606940SMCR606945SMCR606947SMCR606948SMCR606949SMCR606951SMCR606953SMCR606955SMCR606956SMCR606958SMCR606962SMCR606963SMCR606964SMCR606966SMCR606967SMCR606969SMCR606970SMCR606971SMCR606972SMCR606973SMCR606974SMCR606975SMCR606977SMCR606981SMCR606982SMCR606983SMCR606985SMCR606987SMCR606988SMCR606989SMCR606990SMCR606991SMCR606992SMCR606993SMCR606994SMCR606995SMCR606996SMCR606997SMCR606998SMCR606999SMCR607000SMCR607001SMCR607002SMCR607003SMCR607005SMCR607006SMCR607009SMCR607010SMCR607011SMCR607012SMCR607013SMCR607014SMCR607015SMCR607017SMCR607018SMCR607019SMCR607020SMCR607021SMCR607022SMCR607023S
- Amount recalled
- 22244 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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