ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
FDA device recall Z-0421-2024 · posted 2023-12-01 · Open, Classified
Recall details
- Recalling firm
- Medtronic Inc.
- Reason for recall
- 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.
- Action taken
- 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 CareLink: - Consider whether enrolling in CareLink is an option, per HRS/EHRA/APHRS/LAHRS guidance.1 Ongoing CareLink monitoring will reduce the potential for episodes caused by amplified noise to overwrite true episodes before they are reviewed. - If noise interferes with the ability to assess the patient s rhythm or reason for monitoring, contact Medtronic Technical Services for assistance (dxhelp@medtronic.com or 1-800-929-4043). On 06/19/2024, Medtronic sent an additional notice to consignees where they were notified of the additional units identified, encouraged enrollment in and regular transmissions to CareLink. For patients not followed with CareLink, consider enrolling. Hospitals were instructed to return unused units. Physicians were provided patient management recommendations. All consignees were requested to complete a confirmation form.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- MXD
- Quantity affected
- 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,
- Date initiated
- 2023-11-03
- Date posted
- 2023-12-01
- Location
- Mounds View, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LINQ II Insertable Cardiac Monitor (K233562) | Medtronic, Inc. | 2023-12-06 |
| LINQ II™ Insertable Cardiac Monitor (LNQ22) (K233320) | Medtronic, Inc. | 2023-10-31 |
| LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application (K230553) | Medtronic, Inc. | 2023-04-26 |
| LINQ II Insertable Cardiac Monitor (K221962) | Medtronic, Inc. | 2022-08-25 |
| LINQ II Insertable Cardiac Monitor (K211304) | Medtronic, Inc. | 2021-05-28 |
| LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit (K200795) | Medtronic, Inc. | 2020-07-03 |