NAVIGUS STIMLOC (2021-06-04)

Starting date:

June 4, 2021

Posting date:

June 30, 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-75925

Last updated:
2021-06-30

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  Reason
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  Affected products

Affected Products 

NAVIGUS STIMLOC

Reason

Medtronic has identified that specific lots of the Stimloc Clips may have excess nylon molding flash. This issue can prevent the clip from snapping into the StimLoc Base, which could allow for lead movement or lead damage. This could potentially result in delivery of therapy to the wrong location, inadequate delivery of therapy, or intracranial hemorrhage.

Affected products