Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 89469
Description: LINQ II Insertable Cardiac Monitor
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 89469 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0782-2022 |
| Event ID | 89469 |
| Event Description | LINQ II Insertable Cardiac Monitor |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy. |
| Quantity | 8 devices |
| Recall Reason | Devices may lose functionality due to susceptibility to moisture ingress. |
| Device Classification | 20220323 |
| Device 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) |
| Center Classification Date | 20220311 |
| Recall Initiation Date | 20220118 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Letter |
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