LINQ II Insertable Cardiac Monitor recallZ-0782-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated Jan 18, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices may lose functionality due to susceptibility to moisture ingress.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On or around January 18, 2002, in the United States, Medtronic will begin notifying notified customers of the field corrective action and patient management recommendations via 2-day UPS delivery. Consignees were provided with proper patient management recommendations. Consignees are asked to complete and return a confirmation certification confirming they have received the notification. Outside the United States (OUS), communication will begin no later than 18-JAN-2022 using locally approved methods.
Recall details
- Recall number
- Z-0782-2022
- Status
- Terminated
- Initiated by the company
- Jan 18, 2022
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 8 devices
- Product code
- MXD
- FDA submissions
- K200795
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
Product description
LINQ II Insertable Cardiac Monitor
Code information (models, lots, serial numbers)
8 impacted devices with the following Serial number and GTIN 1) Serial RLB035341G (GTIN 00763000060374) 2) Serial RLB051224G (GTIN 00763000060374) 3) Serial RLB059666G (GTIN 00763000060374) 4) Serial RLB061064G (GTIN 00763000060374) 5) Serial RLB061812G (GTIN 00763000060381) 6) Serial RLB066367G (GTIN 00763000060374) 7) Serial RLB091638G (GTIN 00763000060374) 8) Serial RLB122769G (GTIN 00763000554002)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- LINQ II™ LNQ22Medtronic, Inc. · Recorder, event, implantable cardiac, (with arrhythmia detection)2 recalls5,709 reports
- LINQ II™ LNQ22Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA2 recalls673 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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