Recall Z-0421-2024 · MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Medtronic Inc.
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
| Date | Dec 1, 2023 (initiated Nov 3, 2023) |
| Status | Open, Classified |
| Reason | It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference. |
| Root cause | Process change control |
| Action | Medtronic issued a MEDICAL DEVICE PERFORMANCE NOTIFICATION to its consignees on 11/03/2023 via UPS 2-day delivery. The notice explained the issue, potential hazards, and requested the following actions: Encourage enrollment in and regular transmissions to CareLink. - Medtronic will apply recurring algorithmic searches on CareLink for the noise pattern and notify the clinician if present. The information used to identify this pattern is not visible to the clinician through CareLink. No further action is required for patients regularly transmitting to CareLink. For patients not followed in C |
| Quantity | 64,739 units |
| Distribution | US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, Macao, Malaysia, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, Puerto Rico, Saudi Ar |
| 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 |
| K211304 | LINQ II Insertable Cardiac Monitor Medtronic, Inc., May 28, 2021 |
| K221962 | LINQ II Insertable Cardiac Monitor Medtronic, Inc., Aug 25, 2022 |
| K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application Medtronic, Inc., Apr 26, 2023 |
| K233320 | LINQ II Insertable Cardiac Monitor (LNQ22) Medtronic, Inc., Oct 31, 2023 |
| K233562 | LINQ II Insertable Cardiac Monitor Medtronic, Inc., Dec 6, 2023 |