The Recall Desk
HighFDA (Devices)·Z-0782-2022·Announced 2022-03-23

LINQ II Insertable Cardiac Monitor Recalled for Moisture Ingress

Medtronic is recalling 8 LINQ II Insertable Cardiac Monitors due to moisture ingress susceptibility that may cause loss of functionality. Affected devices were distributed in the US (NJ, NY, PA, VA) and Italy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device with a known malfunction risk (loss of functionality due to moisture ingress) but no reported adverse events. This meets the rubric criterion for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medtronic Inc. is recalling 8 LINQ II Insertable Cardiac Monitor devices due to susceptibility to moisture ingress, which may cause the devices to lose functionality.

The affected devices were distributed worldwide, with US distribution in New Jersey, New York, Pennsylvania, and Virginia. One device was also distributed in Italy. Each affected device can be identified by its specific serial number and GTIN as listed in the FDA recall notice.

No specific guidance on patient actions is provided in the recall notice. Patients with affected devices and their healthcare providers should contact Medtronic directly for information about the specific devices and recommended next steps.

The recalled product

Product
LINQ II Insertable Cardiac Monitor
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Cardiac Monitoring
Hazard
  • moisture-ingress
  • malfunction

Distribution

Distributed nationwide across the United States.

Related recalls

Same category