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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

Mandated?Voluntary: Firm initiated
Recall NumberZ-0782-2022
Event ID89469
Event DescriptionLINQ II Insertable Cardiac Monitor
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
Quantity8 devices
Recall ReasonDevices may lose functionality due to susceptibility to moisture ingress.
Device Classification20220323
Device Code Info8 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 Date20220311
Recall Initiation Date20220118
Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Initial Notification Letter
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