Recall Z-0421-2024— Medtronic Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic Inc., initiated 2023-11-03. It names 6 FDA 510(k) clearances: K233562, K233320, K230553 and 3 more. Product: ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor. 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..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-03
- Firm location
- Mounds View, MN, United States
510(k) clearances named in this recall
6 on FDA's record- K233562 — LINQ II Insertable Cardiac Monitor
- K233320 — LINQ II Insertable Cardiac Monitor (LNQ22)
- K230553 — LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
- K221962 — LINQ II Insertable Cardiac Monitor
- K211304 — LINQ II Insertable Cardiac Monitor
- K200795 — LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.