Mycarelink Patient Monitor And Reader (2017-07-19)

Mycarelink Patient Monitor and Reader Recall Summary Medtronic is recalling Mycarelink Patient Monitors and Readers distributed across Canada due to a potential software issue that could cause the device to stop functioning or provide inaccurate information. This recall affects patients who use this remote monitoring device for cardiac care. The FDA has classified this as a Class I recall, indicating the most serious type of safety concern.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2017-09-05

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/0402c7bc-ff0f-4547-a63a-381433de6935