Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.

Is my product affected?

Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.

• UPC 00643169529731

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling approximately 22,244 units of the Micra MC1VR01 cardiac pacemaker distributed worldwide. The company is updating the device's Instructions for Use and Implant Procedure Tip Card to include specific information about removing the tether that releases the Micra Pacemaker from its Delivery System during the implant procedure.

The recall record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide Quantity: 22244 units Lot/code info: GTIN 00643169529731, Serial Numbers: MCR606940S MCR606945S MCR606947S MCR606948S MCR606949S MCR606951S MCR606953S MCR606955S MCR606956S MCR606958S MCR606962S MCR606963S MCR606964S MCR606966S MCR606967S MCR606969S MCR606970S MCR606971S MCR606972S MCR606973S MCR606974S MCR606975S MCR606977S MCR606981S MCR606982S MCR606983S MCR606985S MCR606987S MCR606988S MCR606989S MCR606990S MCR606991S MCR606992S MCR606993S MCR606994S MCR606995S MCR606996S MCR606997S MCR606998S MCR606999S MCR607000S MCR607001S MCR607002S MCR607003S MCR607005S MCR607006S MCR607009S MCR607010S MCR607011S MCR607012S MCR607013S MCR607014S MCR607015S MCR607017S MCR607018S MCR607019S MCR607020S MCR607021S MCR607022S MCR607023S MCR607026S MCR607027S MCR607028S MCR607029S MCR607030S MCR607031S MCR607032S MCR607033S MCR607035S MCR607040S MCR607041S MCR607042S MCR607043S MCR607044S MCR607045S MCR607046S MCR607047S MCR607048S MCR607049S MCR607050S MCR607051S MCR607052S MCR607053S MCR607056S MCR607058S MCR607060S MCR607061S MCR607062S MCR607063S MCR607064S MCR607065S MCR607066S MCR607068S MCR607070S MCR607071S MCR607074S MCR607075S MCR607077S MCR607079S MCR607080S MCR607081S MCR607082S MCR607083S MCR607084S MCR607087S MCR607089S MCR607091S MCR607092S MCR607093S MCR607094S MCR607095S MCR607097S MCR607098S MCR607099S MCR607101S MCR607102S MCR607103S MCR607104S MCR607105S MCR607106S MCR607108S MCR607109S MCR607110S MCR607111S MCR607112S MCR607114S MCR607115S MCR607116S MCR607117S MCR607119S MCR607120S MCR607121S MCR607122S

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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All FDA (Device enforcement) recalls