CLASS II Device recall · Reported 23 Mar 2022 · FDA Enforcement Report
LINQ II Insertable Cardiac Monitor recalled by Medtronic Inc., Cardiac
Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf) is recalling LINQ II Insertable Cardiac Monitor, distributed nationwide in the US. The recall was initiated on 18 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0782-2022
- FDA event ID
- 89469
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf), Mounds View, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jan 2022
- FDA classified
- 11 Mar 2022
- Reported
- 23 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 18 Jan 2022 | Recall initiated by company | |
| 11 Mar 2022 | Classified by FDA | +52 days |
| 23 Mar 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices may lose functionality due to susceptibility to moisture ingress.
Product as listed by the FDA
LINQ II Insertable Cardiac Monitor
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
Questions about this recall
Why was it recalled?
Devices may lose functionality due to susceptibility to moisture ingress.
Which lots are affected?
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)
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf)
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