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

FDA device recall Z-2492-2019 · posted 2019-09-09 · Terminated

Recall details

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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.

Action taken

In the US, beginning 06-Aug-2019, Medtronic Field Representatives are approved to provide the Instructions for Use Update Letter to physicians who have been trained to implant the Micra device as identified by Medtronic training records. Courtesy notifications to Risk Managers at accounts that have purchased Micra and Clinical Principal Investigators (PIs) at sites participating in clinical trials are also approved to be provided. The Instructions for Use Update letter will be sent via 2-day delivery beginning 12-Aug-2019 to the physicians and risk managers.

Root cause

Other

Status

Terminated

Product code

PNJ

Quantity affected

24521 units

Distribution

Worldwide

Date initiated

2019-08-06

Date posted

2019-09-09

Date terminated

2023-06-26

Location

Mounds View, MN