FDA Device recall Z-2492-2019

Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only)

FDA Device
Class II
terminated
Published 2019-09-18

On 2019-09-18 the FDA classified a Class II recall of Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only) by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing 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 Mic….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2492-2019
Classification	Class II
Status	terminated
Initiated	2019-08-06
Published	2019-09-18
Last updated	2026-09-13 11:55 UTC
Company	Medtronic Cardiac Rhythm And Heart Failure Crhf
Distribution	n/a

Product

Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.

Reason

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.

Identifiers

code_info	REF MC1VR01US, GTIN 00643169529748, Serial Numbers: MCR610462S MCR610483S MCR610486S MCR610498S MCR610503S MCR610… REF MC1VR01US, GTIN 00643169529748, Serial Numbers: MCR610462S MCR610483S MCR610486S MCR610498S MCR610503S MCR610514S MCR610516S MCR610517S MCR610523S MCR610525S MCR610526S MCR610527S MCR610529S MCR610533S MCR610537S MCR610538S MCR610542S MCR610543S MCR610546S MCR610547S MCR610551S MCR610554S MCR610555S MCR610556S MCR610557S MCR610567S MCR610569S MCR610570S MCR610571S MCR610572S MCR610577S MCR610579S MCR610582S MCR610583S MCR610584S MCR610586S MCR610587S MCR610592S MCR610593S MCR610595S MCR610598S MCR610599S MCR610600S MCR610605S MCR610608S MCR610614S MCR610615S MCR610618S MCR610635S MCR610642S MCR610643S MCR610645S MCR610646S MCR610647S MCR610649S MCR610653S MCR610655S MCR610656S MCR610657S MCR610659S MCR610669S MCR610677S MCR610689S MCR610690S MCR610692S MCR610697S MCR610709S MCR610713S MCR610715S MCR610844S MCR610846S MCR610849S MCR610852S MCR610857S MCR610860S MCR610870S MCR610872S MCR610877S MCR610878S

code_info

REF MC1VR01US, GTIN 00643169529748, Serial Numbers: MCR610462S MCR610483S MCR610486S MCR610498S MCR610503S MCR610…

REF MC1VR01US, GTIN 00643169529748, Serial Numbers: MCR610462S MCR610483S MCR610486S MCR610498S MCR610503S MCR610514S MCR610516S MCR610517S MCR610523S MCR610525S MCR610526S MCR610527S MCR610529S MCR610533S MCR610537S MCR610538S MCR610542S MCR610543S MCR610546S MCR610547S MCR610551S MCR610554S MCR610555S MCR610556S MCR610557S MCR610567S MCR610569S MCR610570S MCR610571S MCR610572S MCR610577S MCR610579S MCR610582S MCR610583S MCR610584S MCR610586S MCR610587S MCR610592S MCR610593S MCR610595S MCR610598S MCR610599S MCR610600S MCR610605S MCR610608S MCR610614S MCR610615S MCR610618S MCR610635S MCR610642S MCR610643S MCR610645S MCR610646S MCR610647S MCR610649S MCR610653S MCR610655S MCR610656S MCR610657S MCR610659S MCR610669S MCR610677S MCR610689S MCR610690S MCR610692S MCR610697S MCR610709S MCR610713S MCR610715S MCR610844S MCR610846S MCR610849S MCR610852S MCR610857S MCR610860S MCR610870S MCR610872S MCR610877S MCR610878S

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2492-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.