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Recall Observatory FDA recall evidence

Device product

LINQ II Insertable Cardiac Monitor

Z-0782-2022

January 18, 2022

Class II

Product summary

Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event
Event 89469
Status
Terminated
Classification
Class II
Quantity
8 devices
Official record key
device-enforcement:Z-0782-2022

Official wording

Reason: Devices may lose functionality due to susceptibility to moisture ingress.

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)

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Devices may lose functionality due to susceptibility to moisture ingress.