Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) LINQ II Insertable Cardiac Monitor Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LINQ II Insertable Cardiac Monitor
Brand
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling LINQ II Insertable Cardiac Monitor due to Devices may lose functionality due to susceptibility to moisture ingress.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices may lose functionality due to susceptibility to moisture ingress.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026