LINQ II Insertable Cardiac Monitor
- Recall Initiated
- January 18, 2022
- Recall Number
- Z-0782-2022
- Quantity
- 8 devices
- Firm Location
- Mounds View, MN
Reason for Recall
Devices may lose functionality due to susceptibility to moisture ingress.
Distribution
Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
Lot / Code Info
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)
Root Cause
Nonconforming Material/Component
Action Taken
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.