Z-0782-2022 Class II Terminated
FDA device recall Z-0782-2022 was initiated by Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) on Jan 18, 2022 and is designated Class II. Reason for recall: Devices may lose functionality due to susceptibility to moisture ingress. The recall status is terminated (terminated May 4, 2026). Affected quantity: 8 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 23, 2022
- Initiation Date
- Jan 18, 2022
- Termination Date
- May 4, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 devices
Product Description
LINQ II Insertable Cardiac Monitor
Reason for Recall
Devices may lose functionality due to susceptibility to moisture ingress.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
Code Information
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0782-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026