FDA Medical Device Recalls (openFDA)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): LINQ II Insertable Cardiac Monitor
- Recall number
- Z-0782-2022
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Product
- LINQ II Insertable Cardiac Monitor
- Status
- Terminated
- Initiated
- 2022-01-18
- Posted
- not on file
- Terminated
- 2026-05-04
- Reason
- Devices may lose functionality due to susceptibility to moisture ingress.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 8 devices
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K200795"]
- PMA numbers
- not on file
- Product code
- MXD
- Firm FEI
- 2182208
- Firm city
- Mounds View
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28