FDA recall Z-0782-2022
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Class II · device
Product
LINQ II Insertable Cardiac Monitor
Reason for recall
Devices may lose functionality due to susceptibility to moisture ingress.
Distribution
Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
Key facts
- Status
- Terminated
- Initiation date
- 2022-01-18
- Report date
- 2022-03-23
- Termination date
- 2026-05-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Mounds View, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0782-2022