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Mycarelink Patient Monitor and Reader (2017-07-19)
- Starting date:
- July 19, 2017
- Posting date:
- September 5, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-64414
Affected Products
- Mycarelink Patient Monitor
- Mycarelink Smart Patient Reader
Reason
Purpose of this notification is to provide important information regarding instructions for use (IFU) update related to patients monitored on the Medtronic CareLink network with two (2) or more implanted Medtronic heart devices. If a patient has multiple devices, there are potential impacts on the ability to remotely monitor that patient's heart devices. These potential impacts could lead to missed CareAlert notifications or device reports.
Affected products
A. Mycarelink Patient Monitor
Lot or serial number
All lots
Model or catalog number
24950
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
B. Mycarelink Smart Patient Reader
Lot or serial number
All lots
Model or catalog number
25000
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES