LINQ II Insertable Cardiac Monitor (2021-06-02)

Starting date:

June 2, 2021

Posting date:

June 17, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-75821

Last updated:
2021-06-17

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  Reason
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  Affected products

Affected Products

LINQ II Insertable Cardiac Monitor

Reason

Medtronic has identified that Reveal LINQ with Trurhythm ICMS that undergo a partial electrical reset appear to be programmed "ON," but are no longer able to detect and report brady and pause events. A partial electrical reset is normal behavior that can occur when the device detects a possible issue with the device software. However, an error in the partial electrical reset implementation is causing this unintended behavior. There have been zero (0) serious or permanent harms or deaths reported as a result of this issue. After a partial electrical reset, these brady and pause episode types will not be reported to the clinician. Potential harms include those associated with the risk of a delayed medical intervention or missed diagnosis for brady and pause events, and an explant procedure.

Affected products