Reveal LINQ insertable Cardiac Monitor — Class II medical device recall Z-1249-2016
Terminated recall by Medtronic Inc., reported 2016-04-06, distributed nationwide. Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may pr
| Recall number | Z-1249-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Saint Paul, MN, United States |
| Recall initiated | 2016-02-23 |
| Classified | 2016-03-25 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2017-09-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, CA, CH, CN, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IR, IS, IT, KE, KW, LT, LU, LV, MT, MY, NL, NO, NZ, OM, PH, PL, PT, QA, RS, SA, SE, SG, SI, SK, TH, TR, ZA |
| Quantity | 189,009 |
| Reason classes | software |
| Model numbers | LNQ11 |
Product
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
Reason for recall
Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery capacity is not affected and the device will continue to support data collection and manual data transmissions. As part of the normal behavior of the device, 30 days after RRT status is reached, Reveal
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-1249-2016. 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.