ICM LNQ22 LINQ II — Class II medical device recall Z-0421-2024
Ongoing recall by Medtronic Inc., reported 2023-12-06, distributed in PR. It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfer
| Recall number | Z-0421-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Mounds View, MN, United States |
| Recall initiated | 2023-11-03 |
| Classified | 2023-11-30 |
| Reported by FDA | 2023-12-06 |
| Distributed | PR |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, GR, HK, IE, IL, IS, IT, JP, LU, MY, NL, NO, NZ, PT, SA, SE, SG, SK, ZA |
| Quantity | 64,739 units |
| UPC / GTIN / UDI-DI | 00763000060374, 00763000060381, 00763000553999, 00763000554002, 00763000613747, 00763000635114, 00763000871642 |
| Serial numbers | 2105G, 3670G, 4750G, 5366G, 6862G, 8370G, 8875G, B056159G, LB144907G, LB163273G, LB474102G, LB648750G, LB706182G, RLB030037G, RLB030046G, RLB030051G, RLB030052G, RLB030053G, RLB030055G, RLB030058G, RLB030061G, RLB030079G, RLB030081G, RLB030173G, RLB030189G and 475 more |
| Model numbers | LNQ22 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0421-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.