LINQ II Insertable Cardiac Monitor
FDA Recall Z-0782-2022 · Posted None
Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Recall StatusTerminated
Product CodeMXD
Date Initiated2022-01-18
Date Terminated2026-05-04
Product Quantity8 devices
Reason for Recall
Devices may lose functionality due to susceptibility to moisture ingress.
Firm Action
On or around January 18, 2002, in the United States, Medtronic will begin notifying notified customers of the field corrective action and patient management recommendations via 2-day UPS delivery. Consignees were provided with proper patient management recommendations. Consignees are asked to complete and return a confirmation certification confirming they have received the notification.
Outside the United States (OUS), communication will begin no later than 18-JAN-2022 using locally approved methods.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.