Recall Z-0782-2022 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
LINQ II Insertable Cardiac Monitor
| Date | Jan 18, 2022 |
| Status | Terminated |
| Reason | Devices may lose functionality due to susceptibility to moisture ingress. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 8 devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool K Medtronic, Inc., Jul 3, 2020 |